The Multi-Strategy Intervention to Enhance Quality of Anesthesia Care for Obese Patients: A Factorial Randomized Controlled Trial

NCT05016076 NA WITHDRAWN

The main objective of this study is to investigate the optimal anesthesia for obese patients undergoing bariatric surgery in the strategies of positive pulmonary ventilation, tracheal intubation technique, hemodynamic monitoring, and postoperative nausea and vomiting (PONV) prophylaxis, as the followed: 1. To evaluate the effectiveness and adverse effect of intravenous dexamethasone for PONV prophylaxis 2. To determine the safe inspiratory pressure to prevent the occurrence of gastric insufflation during facemask ventilation using point-of-care ultrasonography of antrum 3. To compare the effectiveness and safety between video intubating stylet and video laryngoscope in the placement of tracheal tubes 4. To apply minimally invasive CO monitors in guiding goal-directed hemodynamic therapy and assess its impact on major complications and postoperative recovery

Details

Lead sponsor	YingHsuanTai
Phase	NA
Status	WITHDRAWN
Start date	2022-05
Completion	2023-08

Conditions

• Obesity
• Bariatric Surgery Candidate
• Tracheal Intubation Morbidity
• Nausea and Vomiting, Postoperative
• Hyperglycemia Drug Induced
• Gastric Reflux

Interventions

• Dexamethasone 8 mg
• Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)
• Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy
• Goal-directed hemodynamic therapy targeting cardiac index
• Placebo (0.9% sodium chloride)

Primary outcomes

• Substudy 1: Number of participants developing postoperative nausea and vomiting — The first 24 postoperative hour
  Primary outcome is postoperative nausea and vomiting, which includes any nausea, emetic episodes (retching or vomiting), or both during the first 24 postoperative hour. At the 2nd and 24th postoperative hours, trained investigators who are blinded to the group allocation will record the number of emetic episodes, the time each one occurs, and self-reported worst nausea episode during the preceding duration on an 11-point scale (0: no nausea and 10: the most severe nausea).
• Substudy 2: The threshold inspiratory pressure for gastric insufflation — Within 2 min after induction of anesthesia
  Primary outcome is the episode of gastric insufflation. The ultrasonographic diagnosis of gastric insufflation is defined as the presence of an acoustic shadow phenomenon and/or a comet-tail artifact into the antrum. A typical whoosh sound with gurgling while auscultating over the epigastrium defines the diagnosis of gastric insufflation by auscultation method.
• Substudy 3: The best glottis visualization, graded according to Cormack and Lehane's classification — From the induction of anesthesia to the 24th postoperative hours
  Primary outcome is the best glottis visualization, graded according to Cormack and Lehane's classification with external laryngeal pressure applied. The minimum and maximum values of Cormack and Lehane's grade are I and IV, respectively. Glottic views graded as III or IV are regarded as difficult.
• Substudy 4: Number of participants developing postoperative major complications — Within 30 days after surgery
  Primary outcome is a composite of major complications according to the European Perioperative Clinical Outcome definitions within 30 days after surgery, including myocardial ischemia or infarction, arrhythmia, acute kidney injury, gastrointestinal bleeding, anastomotic breakdown, surgical site infection, and hospital-acquired pneumonia. Any events of the above complications will be determined and analyzed aggregately and separately.

Countries

Taiwan