Surgical Conditions During Laparoscopic Bariatric Surgery

• ClinicalTrials.gov Identifier: NCT02703909
• Recruitment Status: Completed
• First Posted: March 9, 2016
• Results First Posted: June 21, 2018
• Last Update Posted: June 21, 2018
• Sponsor: University of Missouri-Columbia
• Collaborator: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Terri Monk, University of Missouri-Columbia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Morbid Obesity	Drug: Rocuronium; Device: Insufflation pressure	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 144 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Health Services Research
• Official Title: A Prospective Randomized Clinical Trial Evaluating Surgical Conditions During Laparoscopic Bariatric Surgery With Deep Versus Moderate Neuromuscular Blockade
• Actual Study Start Date: May 2016
• Actual Primary Completion Date: May 30, 2017
• Actual Study Completion Date: October 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: moderate NMB + 10 mm IP; participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate neuromuscular block (NMB) which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.	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; Other Name: Zemuron; Device: Insufflation pressure; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment; Other Name: intra-abdominal pressure
Active Comparator: moderate NMB + 15 mm IP; participants will be given the muscle relaxant, rocuronium, iv to obtain a moderate NMB which is defined as 2-3 twitches in the train of four on a neuromuscular junction monitor. The initial insufflation pressure for the laparoscopy will be 15 mm Hg pressure. This arm represents the usual operating conditions for this type of surgery at the University hospital.	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; Other Name: Zemuron; Device: Insufflation pressure; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment; Other Name: intra-abdominal pressure
Experimental: deep NMB + 10 mm IP; participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 10 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.	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; Other Name: Zemuron; Device: Insufflation pressure; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment; Other Name: intra-abdominal pressure
Experimental: deep NMB + 15 mm IP; participants will be given the muscle relaxant, rocuronium, iv to obtain a deep NMB which is defined as 0-1 posttetanic counts on a neuromuscular junction monitor and the initial insufflating pressure will be 15 mm Hg. The initial insufflation pressure for the laparoscopy will be 10 mm Hg pressure.	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; Other Name: Zemuron; Device: Insufflation pressure; The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment; Other Name: intra-abdominal pressure

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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:

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Missouri

University Hospital

Columbia, Missouri, United States, 65212

Sponsors and Collaborators

University of Missouri-Columbia

Merck Sharp & Dohme Corp.

Investigators

• Principal Investigator: Terri G Monk, MD; University of Missouri-Columbia

  Study Documents (Full-Text)

Documents provided by Terri Monk, University of Missouri-Columbia:

Study Protocol and Statistical Analysis Plan  [PDF] January 5, 2016

More Information

• Responsible Party: Terri Monk, Professor, Anesthesiology, University of Missouri-Columbia
• ClinicalTrials.gov Identifier: NCT02703909
• Other Study ID Numbers: 2004620
• First Posted: March 9, 2016
• Results First Posted: June 21, 2018
• Last Update Posted: June 21, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Terri Monk, University of Missouri-Columbia:

morbid obesity; laparoscopic surgery; neuromuscular blockade

Additional relevant MeSH terms:

Obesity, Morbid; Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Rocuronium; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Neuromuscular Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs