Surgical Conditions During Laparoscopic Bariatric Surgery
Completed · Phase 4
Conditions studied: Morbid Obesity
In brief
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.
Key facts
- Study ID
- NCT02703909
- Run by
- University of Missouri-Columbia
- People needed
- 144
- Starts
- 2016-05-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2018-06-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- ASA I-III
- BMI ≥ 35
You may not qualify if…
- 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
Where it is running
- University Hospital — Columbia, Missouri, United States
Full record on ClinicalTrials.gov
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