Study protocol of a randomised controlled trial comparing perioperative intravenous insulin, GIK or GLP-1 treatment in diabetes-PILGRIM trial.

BACKGROUND: Diabetes mellitus (DM) is associated with poor outcome after surgery. The prevalence of DM in hospitalised patients is up to 40%, meaning that the anaesthesiologist will encounter a patient with DM in the operating room on a daily basis. Despite an abundance of published glucose lowering protocols and the known negative outcomes associated with perioperative hyperglycaemia in DM, there is no evidence regarding the optimal intraoperative glucose lowering treatment. In addition, protocol adherence is usually low and protocol targets are not simply met. Recently, incretins have been introduced to lower blood glucose. The main hormone of the incretin system is glucagon-like peptide-1 (GLP-1). GLP-1 increases insulin and decreases glucagon secretion in a glucose-dependent manner, resulting in glucose lowering action with a low incidence of hypoglycaemia. We set out to determine the optimal intraoperative treatment algorithm to lower glucose in patients with DM type 2 undergoing non-cardiac surgery, comparing intraoperative glucose-insulin-potassium infusion (GIK), insulin bolus regimen (BR) and GPL-1 (liragludite, LG) treatment. METHODS/DESIGN: This is a multicentre randomised open label trial in patients with DM type 2 undergoing non-cardiac surgery. Patients are randomly assigned to one of three study arms; intraoperative glucose-insulin-potassium infusion (GIK), intraoperative sliding-scale insulin boluses (BR) or GPL-1 pre-treatment with liraglutide (LG). Capillary glucose will be measured every hour. If necessary, in all study arms glucose will be adjusted with an intravenous bolus of insulin. Researchers, care givers and patients will not be blinded for the assigned treatment. The main outcome measure is the difference in median glucose between the three study arms at 1 hour postoperatively. We will include 315 patients, which gives us a 90% power to detect a 1 mmol l(-1) difference in glucose between the study arms. DISCUSSION: The PILGRIM trial started in January 2014 and will provide relevant information on the perioperative use of GLP-1 agonists and the optimal intraoperative treatment algorithm in patients with diabetes mellitus type 2. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02036372.

['Postoperative pain treatment' practice guideline revised]. / Herziene richtlijn 'Postoperatieve pijn'.

On the initiative of the Dutch Association of Anaesthesiologists, a multidisciplinary workgroup has revised the 2003 practice guideline on 'Postoperative pain treatment' for adults and children. The main reason for revision was the availability of new drugs and new methods of administration. The most important deviations from the previous edition are the following. The organisation of care has been amended according to the current themes of the Safety Management System in the Netherlands, and a prediction model for postoperative pain was added. The drugs oxycodone, S-ketamine, pregabalin, gabapentin and metamizole were added, as well as new methods of administration and techniques for preventing postoperative pain. This revised guideline is more conservative than the previous one in the choice of epidural analgesia. In patients with relative contraindications for epidural analgesia, peripheral and locoregional blocks or multimodal pain treatment are advised. In the case of postoperative nausea and vomiting, administration of dexamethasone, droperidol and 5-HT3-antagonists is recommended, preferably in combination. Non-medicinal treatment options are not recommended.

[Hypoxaemia and bradycardia in children during guillotine adenotonsillectomy without intubation]. / Hypoxemie en bradycardie bij kinderen tijdens adenotonsillectomie volgens Sluder zonder intubatie.

OBJECTIVE: To study the incidence of hypoxaemia and bradycardia in children who undergo guillotine adenotonsillectomy in a sitting position, without intubation and under inhalation anaesthesia. DESIGN: Retrospective study. METHOD: Analysis of age, weight, sex, oxygen saturation, heart rate and subsequent bleeding in all children up to the age of 11 years who underwent guillotine adenotonsillectomy in the period December 1999 to December 2007. Hypoxaemia was defined as oxygen saturation of less than 85% for longer than 60 s. Bradycardia was defined as a heart rate of less than 60/min for longer than 30 s. RESULTS: We analysed data from 2963 patients. The mean age was 4.7 years and mean weight 18.8 kg. There was no significant relationship between age, weight and the onset of incidental desaturation or bradycardia. A total of 132 patients (4.5%) had hypoxaemia and 280 patients (9.4%) had bradycardia. Twenty-five patients had both hypoxaemia and bradycardia, of whom 3 (0.1%) had bradycardia immediately following hypoxaemia. In none of the recorded episodes of hypoxaemia and bradycardia did this lead to peri- or postoperative complications. CONCLUSION: Hypoxaemia and bradycardia occurred during guillotine adenotonsillectomy in non-intubated children in a sitting position under inhalation anaesthesia. The simultaneous onset of hypoxaemia and bradycardia is rare, however, and does not lead to perioperative complications. A further study is required using adenotonsillectomy with a large number of intubated and non-intubated children in order to compare the incidence of hypoxaemia and bradycardia and the occurrence of complications.

Large-dose intrathecal sufentanil prevents the hormonal stress response during major abdominal surgery: a comparison with intravenous sufentanil in a prospective randomized trial.

We studied the effect of large-dose intrathecal sufentanil (ITS) for major abdominal surgery on the hormonal stress response. Forty patients were randomly allocated to receive either IV sufentanil (IVS) or 150 microg of ITS as part of general anesthesia. In the IVS group, adrenocorticotropic hormone (ACTH) and cortisol concentrations were larger than baseline and the ITS group, 60 min after incision and at skin closure. Plasma concentrations of cortisol and ACTH were not different from baseline in the ITS group during surgery. Six hours after skin closure, cortisol concentrations were larger than baseline in both groups. Twenty-four and 48 h after skin closure, ACTH and cortisol values were similar between groups. Norepinephrine concentrations increased after surgery in both groups. Blood glucose levels increased in both groups during and after surgery. Pain scores and morphine consumption during the first 48 h after surgery were lower in the ITS group. The data show that large-dose ITS prevents the intraoperative hormonal stress response in comparison with balanced anesthesia. We speculate that this is due to the highly specific binding of sufentanil to spinal and supraspinal receptors. This technique improves postoperative analgesia when compared with balanced anesthesia.