Surgical Conditions During Laparoscopic Bariatric Surgery

NCT ID: NCT02703909

Last Updated: 2018-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2017-10-31

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

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

Insufflation pressure

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Rocuronium

Intervention Type: DRUG

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

Insufflation pressure

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

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

Insufflation pressure

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Rocuronium

Intervention Type: DRUG

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

Insufflation pressure

Intervention Type: DEVICE

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

Interventions

Rocuronium

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

Intervention Type: DRUG

Insufflation pressure

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

Intervention Type: DEVICE

Other Intervention Names

Zemuron; intra-abdominal pressure

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

Terri Monk

Professor, Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Terri G Monk, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University Hospital

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2004620

Identifier Type: -

Identifier Source: org_study_id