NCT02703909

Surgical Conditions During Laparoscopic Bariatric Surgery

A Prospective Randomized Clinical Trial Evaluating Surgical Conditions During Laparoscopic Bariatric Surgery With Deep Versus Moderate Neuromuscular Blockade

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: University of Missouri-Columbia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Obesity affects more than 78 million adults in the United States and it is estimated that 35% of the US population is obese. Currently, more than 179,000 bariatric procedures are performed in the US each year with the majority of these surgeries using laparoscopic techniques. Surgeons often request deep neuromuscular blockade (NMB) during surgery, but there is no evidence that a deep NMB improves surgical conditions and that the surgeons can discriminate between a moderate and deep NMB. There is also evidence that maintaining low insufflation pressures during laparoscopic surgery may decrease postoperative pain. The goal of this prospective, randomized, assessor-blinded controlled trial is to test the hypothesis that deep NMB provides optimal surgical conditions during laparoscopic bariatric surgery in the morbidly obese patient. It will also determine if deep NMB allows the surgeon to utilize lower insufflation pressure and decreases postoperative pain requirements after laparoscopic bariatric surgery.

Detailed description

Subjects will be randomized to one of four groups: 1. moderate neuromuscular block (NMB) + 10 mm insufflation pressure (IP); 2. moderate NMB + 15 mm IP; 3. deep NMB + 10 mm IP; or 4. deep NMB + 15 mm IP. A moderate NMB block will be defined as 2-3 twitches in the train of four (TOF) and a deep NMB will be defined as 0-1 posttetanic count. The surgeons will be asked to rate their satisfaction with the surgical conditions using a five-point ordinal scale ranging from 1 (extremely poor) to 5 (optimal conditions). The first rating will occur at the beginning of the procedure when the NMB level is stable at either a deep or moderate block and the intra-abdominal pressure is either 10 or 15 mm Hg (per randomization). The surgeon will be blinded to the insufflation pressure at this point. If the surgical conditions are rated as extremely poor or poor, the level of the neuromuscular block can be increased and/or the insufflation pressure can be increased to 15 mm Hg.

Conditions

• Morbid Obesity

Interventions

Type	Name	Description
DRUG	Rocuronium	Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
DEVICE	Insufflation pressure	The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment

Timeline

• Start date: 2016-05-01
• Primary completion: 2017-05-30
• Completion: 2017-10-01
• First posted: 2016-03-09
• Last updated: 2018-06-21
• Results posted: 2018-06-21

Locations

1 site across 1 country: United States