Phase 4
N=144
Surgical Conditions During Laparoscopic Bariatric Surgery
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02703909 ↗Enrolled (actual)
144
Serious AEs
0.0%
Results posted
Jun 2018
Primary outcome: Primary: Surgeon Satisfaction Scale — 2.7; 4.1; 3.1; 4.6 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rocuronium (Drug); Insufflation pressure (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Surgeon Satisfaction Scale |
2.7; 4.1; 3.1; 4.6 | — |
| SECONDARY Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure |
10; 0; 14; 0 | — |
| SECONDARY Postoperative Opioid Requirement |
48.8; 56.7 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02703909). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.