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Completed

NCT Number: NCT02703909

Surgical Conditions During Laparoscopic Bariatric Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Columbia, Missouri, 65212, United States

About this study

Subjects will be randomized to one of four groups:

  • moderate neuromuscular block (NMB) + 10 mm insufflation pressure (IP);
  • moderate NMB + 15 mm IP;
  • deep NMB + 10 mm IP; or
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment

Other names: Zemuron

Insufflation pressure

Device

The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment

Other names: intra-abdominal pressure

Primary outcomes

  1. Surgeon Satisfaction Scale

    Time frame: day of surgery

    The surgeon will grade his satisfaction with the surgical conditions using a 5 point scale with 1 - extremely poor; 2 - poor; 3 - acceptable; 4. good; 5 - optimal surgical conditions

Secondary outcomes

  1. Number and Percentage of Subjects With Success at Low (10 mm) Insufflation Pressure

    Time frame: day of surgery

    The patients will be randomized to an initial insufflation pressure of 10 or 15 mm hg. If the surgeons are not satisfied with the initial operating conditions, the insufflating pressure will be increase to 15 mm Hg (if not already at that level). This will be reported as the percentage of patients who were able to have their entire surgery performed at an insufflation pressure of 10 mm Hg.

  2. Postoperative Opioid Requirement

    Time frame: day of surgery until hospital discharge (approximately 2-3 days)

    The participants will be given iv fentanyl or hydromorphone after surgery. They will also be given po oxycodone. The investigators will collect data on the amount of opioid that is required after surgery. This will be reported as morphine equivalents using the morphine equivalent calculator at:

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2016
Registry last updated
Jun 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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