Clinical trial NCT02703909: Surgical Conditions During Laparoscopic Bariatric Surgery
Official title: A Prospective Randomized Clinical Trial Evaluating Surgical Conditions During Laparoscopic Bariatric Surgery With Deep Versus Moderate Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Morbid Obesity
Keywords: morbid obesity
laparoscopic surgery
neuromuscular blockade
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2016-03-09
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* ASA I-III
* BMI ≥ 35

Exclusion Criteria:

* Inability to obtain written informed consent
* Pregnancy or breastfeeding
* Allergy to rocuronium, sugammadex, or any anesthetic agents used in the protocol
* Known or suspected neuromuscular disorders
* Significant renal disease with a serum creatinine ≥ 2 mg/dl f. Significant liver disease g. A family history of malignant hyperthermia

Primary outcomes:
measure: Surgeon Satisfaction Scale
timeFrame: day of surgery
Secondary outcomes:
measure: Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure
timeFrame: day of surgery
measure: Postoperative Opioid Requirement
timeFrame: day of surgery until hospital discharge (approximately 2-3 days)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University Hospital
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Terri G Monk, MD
role: PRINCIPAL_INVESTIGATOR
References: