Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 3.771
Filtrar
5.
Stomatologiia (Mosk) ; 103(3): 42-49, 2024.
Artigo em Russo | MEDLINE | ID: mdl-38904559

RESUMO

THE AIM OF THE STUDY: Was to improve the quality of treatment in pediatric outpatient dentistry with the effective use of oral sedation. MATERIALS AND METHODS: The study comprised 60 children aged 3-12 years who were undergoing therapeutic/surgical dental treatment. All children's somatic state was assessed as ASAI-II. All children met a number of psychological, anamnestic and procedural criteria. Midazolam and chloropyramine in a dose calculated for the patient's body weight were used as components of oral sedation. The estimated sedation depth was Ramsay II-III. The study included an analysis of objective (the time of comfortable treatment, the amount of treated or removed teeth per visit, the possibility of treatment without anesthesia during further visits) and subjective (the possibility of contact with the child during treatment, behavioral reactions at home and on further visits) criteria. Negative behavioral reactions and dental effects were also assessed. RESULTS: The treatment features correlated with the age category and gender of the patient. In the older age group of 7-12 years, the amount of comfortable treatment time was higher, the possibility of contact with the child reached 100% (which is twice as much as in the younger one), and also a larger number of patients were treated during further visits without an anesthetic aid. At the same time, in the younger age group of 3-6 years, the volume of treatment per visit was higher, since it takes less time to treat a primary tooth than for a permanent one. Side effects (visual hallucinations, diplopia, hyperactivity, tearfulness and aggressiveness) were more often recorded in the younger age group, but emotional instability was equally manifested in both groups. CONCLUSION: In order to maximize the effectiveness of using oral sedation as a method, it is necessary to take into account the duration and traumatism of the proposed procedure, the peculiarities of age psychology and the peculiarities of the psychological development of boys and girls.


Assuntos
Anestesia Dentária , Sedação Consciente , Humanos , Criança , Pré-Escolar , Masculino , Feminino , Anestesia Dentária/métodos , Sedação Consciente/métodos , Midazolam/administração & dosagem , Assistência Odontológica para Crianças/métodos , Hipnóticos e Sedativos/administração & dosagem , Assistência Ambulatorial , Pacientes Ambulatoriais
6.
Int J Med Sci ; 21(8): 1552-1558, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38903925

RESUMO

Background: Continuous intravenous infusion of remimazolam may be suitable for sedation in patients undergoing regional anaesthesia. However, there have been no studies comparing remimazolam and dexmedetomidine for this purpose. This study compared emergence from sedation between dexmedetomidine and remimazolam following continuous intravenous infusion in patients undergoing spinal anaesthesia. Methods: This double-blinded, randomised controlled trial assessed the sedative effects of dexmedetomidine and remimazolam. Following spinal anaesthesia, patients were sedated using continuous intravenous infusion of either dexmedetomidine (D group) or remimazolam (R group).The D group received dexmedetomidine administered at 6 mL/kg/h (6 µg/kg/h) for 10 minutes, followed by 1 mL/kg/h (1 µg/kg/h). The R group received remimazolam administered at 6 mL/kg/h (6 mg/kg/h) for 10 minutes, followed by 1 mL/kg/h (1 mg/kg/h). Sedation levels were evaluated using the Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale. The time to reach MOAA/S ≤ 3 from the start of drug infusion and the time to reach MOAA/S = 5 from the end of infusion were recorded. Hemodynamic parameters and respiratory rate were also monitored. Results: The R group reached MOAA/S ≤ 3 significantly faster than the D group during induction of sedation (4 ± 1 minutes and 11 ± 3 minutes, respectively, p < 0.001). The R group also reached MOAA/S = 5 significantly faster than the D group during emergence from sedation (11 ± 3 minutes and 16 ± 5 minutes, respectively, p < 0.001). Both groups maintained stable hemodynamic parameters and respiratory rate without any significant differences, although the mean heart rate was significantly lower in the D group than in the R group after the start of infusion. Conclusion: Remimazolam demonstrated significantly faster induction of and emergence from sedation compared to dexmedetomidine, with no significant differences in haemodynamics or respiratory depression.


Assuntos
Raquianestesia , Dexmedetomidina , Hipnóticos e Sedativos , Humanos , Dexmedetomidina/administração & dosagem , Dexmedetomidina/efeitos adversos , Raquianestesia/métodos , Masculino , Feminino , Adulto , Hipnóticos e Sedativos/administração & dosagem , Pessoa de Meia-Idade , Método Duplo-Cego , Infusões Intravenosas , Benzodiazepinas/administração & dosagem , Benzodiazepinas/efeitos adversos , Período de Recuperação da Anestesia , Hemodinâmica/efeitos dos fármacos , Sedação Consciente/métodos
8.
Urol Pract ; 11(4): 662-668, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38899653

RESUMO

INTRODUCTION: Penile plication is commonly performed for Peyronie's disease under general or spinal anesthesia. Conscious sedation (CS) offers decreased anesthetic risks, cost-effectiveness, and the ability to perform the procedure in outpatient settings with shorter wait times. We sought to compare tolerability of penile plication under deep intravenous sedation (DIS) administered by anesthesiologists and nursing-administered CS (NACS). METHODS: Tolerability for penile plication was prospectively evaluated, excluding revision surgeries and those with hourglass or hinge deformities. DIS included midazolam and ketamine with infusion of propofol and remifentanil. NACS consisted of midazolam and fentanyl. Baseline characteristics, procedural information, and patient- and surgeon-reported pain assessments were collected. Patients were administered a standardized tolerability questionnaire on follow-up. RESULTS: Forty patients were enrolled (23 DIS; 17 NACS) with similar baseline characteristics. Median curvature of the DIS cohort was 55° (interquartile range = 43.75-76.25) and 45° (interquartile range = 45-60) in NACS. There was a 100% success rate with no procedure abortion or conversion to general anesthetic. On follow-up, all patients had functional curvature (<20°), and 100% of patients in the DIS and NACS cohorts reported that they would recommend CS to others. Over 93% of patients in both cohorts would choose CS over general anesthetic in the future, with no differences in perioperative and postoperative pain between groups. CONCLUSIONS: Penile plication with CS, whether administered by an anesthesiologist or nursing, is well tolerated with no differences in pain or complications. This indicates that outpatient penile plication with trained nursing staff administering CS can safely reduce costs, risks, and wait times.


Assuntos
Procedimentos Cirúrgicos Ambulatórios , Sedação Consciente , Sedação Profunda , Humanos , Masculino , Estudos Prospectivos , Projetos Piloto , Pessoa de Meia-Idade , Sedação Consciente/métodos , Sedação Consciente/efeitos adversos , Sedação Consciente/enfermagem , Procedimentos Cirúrgicos Ambulatórios/métodos , Procedimentos Cirúrgicos Ambulatórios/efeitos adversos , Sedação Profunda/métodos , Sedação Profunda/enfermagem , Sedação Profunda/efeitos adversos , Induração Peniana/cirurgia , Induração Peniana/enfermagem , Idoso , Anestesiologistas , Adulto , Propofol/administração & dosagem , Propofol/efeitos adversos , Midazolam/administração & dosagem , Pênis/cirurgia , Pênis/anatomia & histologia , Fentanila/administração & dosagem
9.
BMC Pulm Med ; 24(1): 301, 2024 Jun 26.
Artigo em Inglês | MEDLINE | ID: mdl-38926768

RESUMO

BACKGROUND: Sedation during flexible bronchoscopy (FB) should maintain an adequate respiratory drive, ensure maximum comfort for the patient, and warrant that the objectives of the procedure are achieved. Nevertheless, the optimal sedation method for FB has yet to be established. This study aimed to compare the standard recommended combination of midazolam-fentanyl (MF) with that of dexmedetomidine-ketamine (DK) for patient sedation during FB. METHODS: Patients subjected to FB were randomly assigned to a DK (n = 25) and an MF group (n = 25). The primary outcome was the rate of critical desaturation events (arterial oxygen saturation < 80% with nasal oxygen supply 2 L/min). Secondary outcomes included sedation depth, hemodynamic complications, adverse events, and patient and bronchoscopist satisfaction. RESULTS: The incidence rates of critical desaturation events were similar between the two groups (DK: 12% vs. MF: 28%, p = 0.289). DK achieved deeper maximum sedation levels (higher Ramsay - lower Riker scale; p < 0.001) and was associated with longer recovery times (p < 0.001). Both groups had comparable rates of hemodynamic and other complications. Patient satisfaction was similar between the two groups, but bronchoscopist satisfaction was higher with the DK combination (p = 0.033). CONCLUSION: DK demonstrated a good safety profile in patients subjected to FB and achieved more profound sedation and better bronchoscopist satisfaction than the standard MF combination without increasing the rate of adverse events.


Assuntos
Broncoscopia , Dexmedetomidina , Fentanila , Hipnóticos e Sedativos , Ketamina , Midazolam , Satisfação do Paciente , Humanos , Dexmedetomidina/administração & dosagem , Dexmedetomidina/efeitos adversos , Broncoscopia/métodos , Fentanila/administração & dosagem , Masculino , Midazolam/administração & dosagem , Midazolam/efeitos adversos , Ketamina/administração & dosagem , Ketamina/efeitos adversos , Feminino , Pessoa de Meia-Idade , Estudos Prospectivos , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversos , Método Simples-Cego , Idoso , Adulto , Sedação Consciente/métodos
10.
BMC Anesthesiol ; 24(1): 191, 2024 May 28.
Artigo em Inglês | MEDLINE | ID: mdl-38807059

RESUMO

BACKGROUND: Balanced propofol sedation is extensively used in endoscopic retrograde cholangiopancreatography (ERCP), but sedation-related adverse events (SRAEs) are common. In various clinical settings, the combination of dexmedetomidine with opioids and benzodiazepines has provided effective sedation with increased safety. The aim of this investigation was to compare the efficacy and safety of dexmedetomidine and propofol for sedation during ERCP. METHODS: Forty-one patients were randomly divided into two groups: the dexmedetomidine (DEX) group and the propofol (PRO) group. Patients in the DEX group received an additional bolus of 0.6 µg kg-1 dexmedetomidine followed by a dexmedetomidine infusion at 1.2 µg kg-1 h-1, whereas the PRO group received 1-2 mg kg-1 of propofol bolus followed by a propofol infusion at 2-3 mg kg-1 h-1. During ERCP, the primary outcome was the incidence of hypoxemia (SpO2 < 90% for > 10 s). Other intraoperative adverse events were also recorded as secondary outcomes, including respiratory depression (respiratory rate of < 10 bpm min-1), hypotension (MAP < 65 mmHg), and bradycardia (HR < 45 beats min-1). RESULTS: The incidence of hypoxemia was significantly reduced in the DEX group compared to the PRO group (0% versus 28.6%, respectively; P = 0.032). Patients in the PRO group exhibited respiratory depression more frequently than patients in the DEX group (35% versus 81%, respectively; P = 0.003). There were no significant differences in terms of hypotension and bradycardia episodes between groups. During the procedures, the satisfaction scores of endoscopists and patients, as well as the pain and procedure memory scores of patients were comparable between groups. CONCLUSION: In comparison with propofol, dexmedetomidine provided adequate sedation safety with no adverse effects on sedation efficacy during ERCP. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2200061468, 25/06/2022.


Assuntos
Colangiopancreatografia Retrógrada Endoscópica , Dexmedetomidina , Hipnóticos e Sedativos , Propofol , Humanos , Dexmedetomidina/administração & dosagem , Dexmedetomidina/efeitos adversos , Colangiopancreatografia Retrógrada Endoscópica/métodos , Propofol/administração & dosagem , Propofol/efeitos adversos , Masculino , Feminino , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversos , Pessoa de Meia-Idade , Estudos Prospectivos , Método Simples-Cego , Idoso , Adulto , Hipóxia/prevenção & controle , Sedação Consciente/métodos
11.
Curr Opin Ophthalmol ; 35(4): 298-303, 2024 Jul 01.
Artigo em Inglês | MEDLINE | ID: mdl-38704652

RESUMO

PURPOSE OF REVIEW: Surgical and anesthetic technological advancement have made both cataract and noncataract anterior segment surgery significantly less invasive and time-intensive, facilitating the transition of some of these procedures from the operating room under monitored anesthesia care (MAC) to the office-based setting without MAC. This transition has been aided by the popularization of nonintravenous approaches to achieving patient sedation for these procedures. In this review, we discuss the literature surrounding traditional and nontraditional methods of achieving patient sedation for anterior segment surgery. RECENT FINDINGS: Our survey of the literature suggests that nonintravenous (IV) approaches to sedation for these procedures may be just as safe, effective, and satisfactory to patients as traditional IV approaches. SUMMARY: As anterior segment surgery becomes less invasive and less time-intensive, providers considering transitioning their cataract and anterior segment surgery out of the operating room and into the office-based setting without MAC anesthesia should consider the non-IV sedation options outlined in this review to achieve adequate patient sedation and comfort.


Assuntos
Segmento Anterior do Olho , Sedação Consciente , Humanos , Sedação Consciente/métodos , Segmento Anterior do Olho/cirurgia , Hipnóticos e Sedativos/administração & dosagem , Extração de Catarata/métodos , Procedimentos Cirúrgicos Oftalmológicos/métodos
12.
Br Dent J ; 236(9): 680-682, 2024 May.
Artigo em Inglês | MEDLINE | ID: mdl-38730155

RESUMO

Nitrous oxide is a widely used and well-established form of inhalation sedation in dentistry. Its properties have a wide margin of safety and allow for anxious, paediatric and adult patients to receive dental treatment with minimal impact upon discharge. Nitrous oxide has drawbacks, however, including its environmental impact and need for specialist equipment. Methoxyflurane is another drug which could prove to be an alternative to nitrous oxide. Methoxyflurane's use has proved popular within emergency medicine in Australia and New Zealand for its potent analgesic effects and recognition of its anxiolytic effect. As a result, its use in invasive outpatient procedures has now become popular. Unfortunately, there is very limited evidence of its use within dentistry as a form of inhalation sedation and analgesic. A wider evidence base should be established, as methoxyflurane could prove to be an effective and environmentally friendly alternative to nitrous oxide.


Assuntos
Anestesia Dentária , Anestésicos Inalatórios , Metoxiflurano , Óxido Nitroso , Humanos , Metoxiflurano/administração & dosagem , Metoxiflurano/uso terapêutico , Metoxiflurano/farmacologia , Óxido Nitroso/administração & dosagem , Anestésicos Inalatórios/administração & dosagem , Anestesia Dentária/métodos , Isoflurano/administração & dosagem , Sedação Consciente/métodos
13.
J Pak Med Assoc ; 74(4): 641-646, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38751254

RESUMO

Objectives: To determine if the integrated pulmonary index detects changes in ventilation status early in patients undergoing gastrointestinal endoscopy under sedation, and to determine the risk factors affecting hypoxia. METHODS: The retrospective study was conducted at the endoscopy unit of a tertiary university hospital in Turkey and comprised data between October 2018 and December 2019 related to patients of either gender aged >18 years who were assessed as American Society of Anaesthesiologists grade I-III and underwent elective lower and upper gastrointestinal endoscopy. Monitoring was done with capnography in addition to standard procedures. Data was analysed using SPSS 23. RESULTS: Of the 154 patients, 94(%) were females and 60(%) were males. The overall mean age was 50.88±11.8 years (range: 20-70 years). Mean time under anaesthesia was 23.58±4.91 minutes and mean endoscopy time was 21.73±5.06 minutes. During the procedure, hypoxia was observed in 42(27.3%) patients, severe hypoxia in 23(14.9%) and apnoea in 70(45.5%). Mean time between apnoea and hypoxia was 12.59±7.99 seconds, between apnoea and serious hypoxia 21.07±17.64 seconds, between integrated pulmonary index score 1 and hypoxia 12.91±8.17 sec, between integrated pulmonary index score 1 and serious hypoxia 21.59±14.13 seconds, between integrated pulmonary index score <7 and hypoxia 19.63±8.89 seconds, between integrated pulmonary index score <7 and serious hypoxia 28.39±12.66 seconds, between end-tidal carbon dioxide and hypoxia 12.95±8.33 seconds, and between end-tidal carbon dioxide and serious hypoxia 21.29±7.55 seconds. With integrated pulmonary index score 1, sensitivity value for predicting hypoxia and severe hypoxia was 88.1% and 95.7%, respectively, and specificity was 67% and 60.3%, respectively. With integrated pulmonary index score <7, the corresponding values were 100%, 100%, 42% and 64.1%, respectively. CONCLUSIONS: Capnographic monitoring, especially the follow-up integrated pulmonary index score, was found to be valuable and reliable in terms of finding both time and accuracy of the risk factor in the diagnosis of respiratory events.


Assuntos
Capnografia , Endoscopia Gastrointestinal , Hipóxia , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Estudos Retrospectivos , Hipóxia/diagnóstico , Capnografia/métodos , Endoscopia Gastrointestinal/métodos , Idoso , Apneia/diagnóstico , Adulto Jovem , Sedação Consciente/efeitos adversos , Sedação Consciente/métodos , Turquia/epidemiologia , Monitorização Fisiológica/métodos
14.
Scand J Trauma Resusc Emerg Med ; 32(1): 39, 2024 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-38693580

RESUMO

BACKGROUND: Procedural sedation and analgesia (PSA) is a technique of administering sedatives to induce a state that allows the patient to tolerate painful procedures while maintaining cardiorespiratory function, a condition that is frequently desired prehospital. Non-physician prehospital clinicians often have a limited scope of practice when it comes to providing analgesia and sedation; sometimes resulting in a crew request for back-up from physician-staffed prehospital services.". This is also the case if sedation is desirable. Advanced practice providers (APPs), who are legally authorized and trained to carry out this procedure, may be a solution when the physician-staffed service is not available or will not be available in time. METHODS: The aim of this study is to gain insight in the circumstances in which an APP, working at the Dutch ambulance service "RAV Brabant MWN" from January 2019 to December 2022, uses propofol for PSA or to provide sedation. With this a retrospective observational document study we describe the characteristics of patients and ambulance runs and evaluates the interventions in terms of safety. RESULTS: During the study period, the APPs administered propofol 157 times for 135 PSA and in 22 cases for providing sedation. The most common indication was musculoskeletal trauma such as fracture care or the reduction of joint dislocation. In 91% of the situations where propofol was used, the predetermined goal e.g. alignment of fractured extremity, repositioning of luxated joint or providing sedation the goal was achieved. There were 12 cases in which one or more adverse events were documented and all were successfully resolved by the APP. There were no cases of laryngospam, airway obstruction, nor anaphylaxis. None of the adverse events led to unexpected hospitalization or death. CONCLUSION: During the study period, the APPs performed 135 PSAs and provided 22 sedations. The success rate of predetermined goals was higher than that stated in the literature. Although there were a number of side effects, their incidences were lower than those reported in the literature, and these were resolved by the APP during the episode of care. Applying a PSA by an APP at the EMS "RAV Brabant MWN" appears to be safe with a high success rate.


Assuntos
Serviços Médicos de Emergência , Humanos , Países Baixos , Estudos Retrospectivos , Masculino , Feminino , Hipnóticos e Sedativos/administração & dosagem , Sedação Consciente/métodos , Pessoa de Meia-Idade , Adulto , Propofol/administração & dosagem , Idoso
15.
Sci Rep ; 14(1): 11806, 2024 05 23.
Artigo em Inglês | MEDLINE | ID: mdl-38782977

RESUMO

This study aimed to evaluate the clinical effects, complications (peri- and postoperative), depth of sedation, recovery times, and changes in anxiety levels in paediatric dental patients receiving intravenous sedation with propofol and ketamine-propofol mixtures. This prospective clinical study included 69 healthy children (ASA 1) aged 3-7 years. The patients were assigned randomly to propofol group (n = 23), which received propofol; 1:3 ketofol group (n = 23), which received 1:3 ketofol; or 1:4 ketofol group (n = 23), which received 1:4 ketofol. The bispectral index (BIS) and Ramsay Sedation Scale (RSS) score were recorded at intervals of 5 min to measure the depth of sedation, and vital signs were evaluated. Peri- and postoperative complications and recovery times were recorded. Anxiety levels were also evaluated using the Facial Image Scale (FIS) and changes in saliva cortisol levels (SCLs) before and after the intravenous sedation procedure. The Kruskal‒Wallis test and Wilcoxon signed-rank test were used to determine pre- and posttreatment parameters. Dunn's test for post hoc analysis was used to determine the differences among groups. Children's pre- and posttreatment anxiety levels did not differ significantly according to FIS scores, and increases in SCLs were detected in 1:3 ketofol and 1:4 ketofol groups after dental treatment was completed. Compared with those in the other groups, the BIS values of the patients in 1:4 ketofol indicated a slightly lower depth of sedation. The recovery time of the patients in 1:3 ketofol was longer than that of patients in propofol and 1:4 ketofol. The incidence of postoperative complications (agitation, hypersalivation, nausea/vomiting, and diplopia) did not differ among the groups. Ketamine-propofol combinations provided effective sedation similar to that of propofol infusion without any serious complications during dental treatment performed under intravenous sedation. The ketofol infusion increased the anxiety level of paediatric dental patients to a greater extent than the propofol infusion.


Assuntos
Ketamina , Propofol , Humanos , Ketamina/administração & dosagem , Ketamina/efeitos adversos , Propofol/administração & dosagem , Propofol/efeitos adversos , Criança , Feminino , Masculino , Pré-Escolar , Estudos Prospectivos , Hipnóticos e Sedativos/administração & dosagem , Hipnóticos e Sedativos/efeitos adversos , Sedação Consciente/métodos , Período de Recuperação da Anestesia , Ansiedade
16.
Int J Pediatr Otorhinolaryngol ; 181: 111981, 2024 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-38749259

RESUMO

OBJECTIVES: Obtaining perfect immobility or sleep in children undergoing ABR auditory brainstem response) testing can be challenging. We examined the effectiveness and safety of intranasal dexmedetomidine for sedation of children undergoing ABR testing. MATERIAL AND METHODS: We included prospectively all patients aged from 1 to 15 years for whom sedation for ABR testing was required, between July 2018 and November 2021. We administered an initial dose of 2.5 µg/kg intranasal dexmedetomidine with a repeat dose of 1 µg/kg if needed 30 min later. Collected data included success rate of sedation, sedation onset and recovery times and incidence of side effects. RESULTS: ABR testing was undertaken successfully in 57 of the 59 patients, giving a total success rate of 96,6 %. (95 % confidence interval 88.5 %-99.1 %). The median time to onset of sleep was 32 ± 18.3 min. The median duration of sedation recovery time was 48 ± 24.7 min. We recorded the adverse effects. Thirty-one patients experienced bradycardia and 28 patients experienced hypotension, all of which resolved without intervention. CONCLUSION: Intranasal dexmedetomidine is an effective, safe, simple of use and noninvasive method for sedation in children. It could have a major role in auditory brainstem response testing, specially in the case of non-cooperative children. REGISTRATION NUMBER OF THE TRIAL: NCT03530371.


Assuntos
Administração Intranasal , Dexmedetomidina , Potenciais Evocados Auditivos do Tronco Encefálico , Hipnóticos e Sedativos , Adolescente , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Sedação Consciente/métodos , Dexmedetomidina/administração & dosagem , Potenciais Evocados Auditivos do Tronco Encefálico/efeitos dos fármacos , Hipnóticos e Sedativos/administração & dosagem , Estudos Prospectivos
20.
BMC Pulm Med ; 24(1): 243, 2024 May 17.
Artigo em Inglês | MEDLINE | ID: mdl-38760702

RESUMO

BACKGROUND: Remimazolam is safe and effective for moderate sedation during flexible bronchoscopy, but its safety and efficacy during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) remains undetermined. The REST trial (NCT06275594) will be a prospective randomized study of remimazolam in patients undergoing EBUS-TBNA with conscious sedation. The primary aim is to evaluate whether remimazolam is safe and effective for moderate sedation during EBUS-TBNA compared to real-world midazolam and on-label midazolam. METHODS: The REST trial will recruit 330 patients from four university hospitals with mediastinal lesions suspected of being lung cancer who are eligible for EBUS-TBNA under moderate sedation. The participants will be randomized into groups using remimazolam, real-world midazolam, and on-label midazolam (US prescribing information dosage) to perform EBUS-TBNA for procedural sedation. The primary endpoint will be procedural success using composite measures. DISCUSSION: The REST trial will prospectively evaluate the efficacy and safety of remimazolam during EBUS-TBNA under moderate sedation. It will provide information for optimizing sedation modalities and contribute to practical benefits in patients undergoing EBUS-TBNA. TRIAL REGISTRATION: ClinicalTrials.gov (NCT06275594). Prospectively registered on 15 February 2024.


Assuntos
Sedação Consciente , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico , Hipnóticos e Sedativos , Neoplasias Pulmonares , Midazolam , Humanos , Estudos Prospectivos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/efeitos adversos , Aspiração por Agulha Fina Guiada por Ultrassom Endoscópico/métodos , Sedação Consciente/métodos , Neoplasias Pulmonares/patologia , Neoplasias Pulmonares/tratamento farmacológico , Midazolam/administração & dosagem , Hipnóticos e Sedativos/administração & dosagem , Benzodiazepinas , Broncoscopia/métodos , Broncoscopia/efeitos adversos , Masculino , Feminino , Ensaios Clínicos Controlados Aleatórios como Assunto , Adulto , Pessoa de Meia-Idade
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA
...