Effects of individualized positive end-expiratory pressure on intraoperative oxygenation in thoracic surgical patients: study protocol for a prospective randomized controlled trial.

BACKGROUND: Intraoperative hypoxemia and postoperative pulmonary complications (PPCs) often occur in patients with one-lung ventilation (OLV), due to both pulmonary shunt and atelectasis. It has been demonstrated that individualized positive end-expiratory pressure (iPEEP) can effectively improve intraoperative oxygenation, increase lung compliance, and reduce driving pressure, thereby decreasing the risk of developing PPCs. However, its effect during OLV is still unknown. Therefore, we aim to investigate whether iPEEP ventilation during OLV is superior to 5 cmH2O PEEP in terms of intraoperative oxygenation and the occurrence of PPCs. METHODS: This study is a prospective, randomized controlled, single-blind, single-center trial. A total of 112 patients undergoing thoracoscopic pneumonectomy surgery and OLV will be enrolled in the study. They will be randomized into two groups: the static lung compliance guided iPEEP titration group (Cst-iPEEP Group) and the constant 5 cmH2O PEEP group (PEEP 5 Group). The primary outcome will be the oxygenation index at 30 min after OLV and titration. Secondary outcomes are oxygenation index at other operative time points, PPCs, postoperative adverse events, ventilator parameters, vital signs, pH value, inflammatory factors, and economic indicators. DISCUSSION: This trial explores the effect of iPEEP on intraoperative oxygenation during OLV and PPCs. It provides some clinical references for optimizing the lung protective ventilation strategy of OLV, improving patient prognosis, and accelerating postoperative rehabilitation. TRIAL REGISTRATION: www.Chictr.org.cn ChiCTR2300073411 . Registered on 10 July 2023.

Effects of transcutaneous electrical acupoint stimulation (TEAS) on postoperative pain in patients undergoing gastric and esophageal ESD surgery: a study protocol for a prospective randomized controlled trial.

BACKGROUND: Post-operative pain of endoscopic submucosal dissection (ESD) is always be overlooked and undertreated by endoscopists. However, the incidence of moderate to severe pain after ESD is as high as 44.9% to 62.8%, which can greatly affect the patient's recovery, reduce their satisfaction, and extend their hospital stay. Transcutaneous electrical acupoint stimulation (TEAS) have been shown to reduce postoperative pain and enhance gastrointestinal (GI) function recovery in patients undergoing abdomen surgery. However, there is no evidence regarding on the effect of TEAS on post-operative pain and complications in patients undergoing ESD. Therefore, we aim to investigate whether perioperative TEAS treatment is superior to the sham acupuncture in terms of post-ESD pain and GI function recovery. METHODS: This study is a prospective, randomized controlled trail, which is single-blinded and in single center. A total of 120 patients undergoing elective gastric and esophageal ESD surgery in Beijing Friendship Hospital, Capital Medical University, will be involved in this study. These individuals will be stratified according to the type of ESD surgery (i.e. gastric or esophageal procedure) and be randomly divided into two groups. L14, PC6, ST36 and ST37 will be stimulated at the TEAS treatment group, and the control group will receive simulation at four sham acupoints. The primary outcome is post-EDS VAS score at the time of entering PACU, 10 min, 20 min, 30 min, 1 h, 2 h, 4 h, 6 h, 18 h, 24 h, 48 h after the surgery. The secondary outcomes include the anesthesia-associated parameters, sedation score, nausea and vomiting score, shivering score, recovery of gastrointestinal function, satisfaction of patients to anesthesia, incidence of postoperative complications, QLQ-C30 life quality scale, and the economic indicators. DISCUSSION: The results of this study will confirm that continuous preventive application of TEAS can alleviate the postoperative pain among patients with gastric and esophageal ESD surgery and accelerate the recovery of post-ESD gastrointestinal function. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR2100052837, registered on November 6, 2021. http://www.chictr.org.cn/showproj.aspx?proj=135892 .

Intraoperative Dexmedetomidine Decreases Postoperative Pain after Gastric Endoscopic Submucosal Dissection: A Prospective Randomized Controlled Trial.

BACKGROUND: Postoperative pain is one of the most common complications after gastric endoscopic submucosal dissection (ESD); however, there have been only a few studies assessing the efficacy of interventions on postoperative pain after gastric ESD. This prospective randomized controlled trial was designed to assess the effect of intraoperative dexmedetomidine (DEX) on postoperative pain after gastric ESD. MATERIALS AND METHODS: A total of 60 patients undergoing elective gastric ESD under general anesthesia were randomly divided into the DEX group receiving DEX with a loading dose of 1 µg/kg, followed by a maintenance dose of 0.6 µg/kg/h until 30 min before the end of the endoscopic procedure, and the control group receiving normal saline. The primary outcome was the visual analog scale (VAS) score of postoperative pain. Secondary outcomes were the dosage of morphine for postoperative pain control, hemodynamic changes during the observable period, the occurrence of adverse events, lengths of postanesthesia care unit (PACU) and hospital stays, and patient satisfaction. RESULTS: The incidence of postoperative moderate to severe pain was 27% and 53% in the DEX and control groups, respectively, with a significant difference. Compared to the control group, VAS pain scores at 1 h, 2 h, and 4 h postoperatively, the dosage of morphine in the PACU, and the total dosage of morphine within 24 h postoperatively were significantly decreased in the DEX group. Both incidences of hypotension and use of ephedrine in the DEX group were significantly decreased during surgery, but they were significantly increased in the postoperative period. Postoperative nausea and vomiting scores were decreased in the DEX group; however, the length of PACU stay, patient satisfaction, and duration of hospital stay were not significantly different between groups. CONCLUSION: Intraoperative DEX can significantly decrease postoperative pain level, with a slightly reduced dosage of morphine and a decreased severity of postoperative nausea and vomiting after gastric ESD.

Efficacy of dexmedetomidine on postoperative pain in patients undergoing gastric and esophageal endoscopic submucosal dissection: a study protocol for a randomized controlled prospective trial.

BACKGROUND: Endoscopic submucosal dissection (ESD) is widely used as an effective treatment of early gastric and esophageal tumors, as it is minimally invasive, safe, and convenient. Epigastric pain is a common complication of ESD. In the traditional cognition, the postoperative pain of ESD is not serious and does not attach too much attention. However, previous studies found that the incidence of moderate to severe pain after ESD can be as high as 44.9~62.8%. At present, there is no unified understanding of how to carry out good postoperative analgesia in patients undergoing ESD of stomach and esophagus. The purpose of present study is to investigate the efficacy of intraoperative dexmedetomidine (DEX) using on postoperative pain though observing the postoperative visual analog scale (VAS) score within 48 h after ESD surgery, so as to explore an effective analgesia and anesthetic method in patients undergoing gastric and esophagus ESD. METHODS/DESIGN: This study is a prospective, single-center, two-arm, randomized control trail. In total, 120 patients undergoing endoscopic submucosal dissection were stratified by type of surgery (i.e., gastric or esophagus ESD) and randomized into two treatment groups, DEX group (group D, n = 60) and control group (group C, n = 60). Patients in the experimental group (DEX group) will be administrated a loading dose of DEX at 1 µg/kg for 15 min and a continuous infusion at 0.6 µg/kg/h until 30 min before the end of operation. In control group, the same volume of normal saline was infused. The primary outcome is VAS at 2 h after ESD surgery. The secondary outcome will be VAS at 1 h, 4 h, 6 h,18 h, 24 h, and 48 h, the status of perioperative hemodynamics, the use of remedial analgesics, sedation score, shivering, postoperative nausea and vomiting (PONV), and satisfaction scores of patient and complication of ESD (such as bleeding, perforation, aspiration pneumonia). DISCUSSION: The results of this study will demonstrate that intraoperative application of DEX is beneficial for postoperative pain treatment in patients undergoing ESD. This study will not only confirm that postoperative pain treatment is necessary for patients undergoing ESD but also provides an effective anesthesia method for postoperative analgesia. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR2100043837 , registered on March 4, 2021, http://www.chictr.org.cn .