Surgical Conditions During Laparoscopic Bariatric Surgery

NCT02703909 | Completed Phase 4 Results

• 1 other identifier: 2004620
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity

Keywords

morbid obesity; laparoscopic surgery; neuromuscular blockade

Outcome Measures

Primary Outcomes (1)

• Surgeon Satisfaction Scale

  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

  day of surgery

Secondary Outcomes (2)

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

  day of surgery

• Postoperative Opioid Requirement

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

Study Arms (4)

moderate NMB + 10 mm IP

EXPERIMENTAL

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; Device: Insufflation pressure

moderate NMB + 15 mm IP

ACTIVE COMPARATOR

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; Device: Insufflation pressure

deep NMB + 10 mm IP

EXPERIMENTAL

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; Device: Insufflation pressure

deep NMB + 15 mm IP

EXPERIMENTAL

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; Device: Insufflation pressure

Interventions

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

Also known as: Zemuron

deep NMB + 10 mm IP; deep NMB + 15 mm IP; moderate NMB + 10 mm IP; moderate NMB + 15 mm IP

Insufflation pressure DEVICE

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

Also known as: intra-abdominal pressure

deep NMB + 10 mm IP; deep NMB + 15 mm IP; moderate NMB + 10 mm IP; moderate NMB + 15 mm IP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

University Hospital

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Terri G. Monk, MD, Principal Investigator
• Organization: University of Missouri - Columbia

monkt@health.missouri.edu

(573)-882-2568

Study Officials

• Terri G Monk, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Anesthesiology

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 9, 2016
• Study Start: May 1, 2016
• Primary Completion: May 30, 2017
• Study Completion: October 1, 2017
• Last Updated: June 21, 2018
• Results First Posted: June 21, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)