Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

Status Not yet recruiting

Clinical Trial Summary

This study aims to evaluate the use of deep neuromuscular blockade and low-pressure pneumoperitoneum in bariatric surgery. The investigators propose to conduct a double-blind randomized controlled trial (RCT) comparing deep neuromuscular blockade versus standard blockade, and its impact on operative conditions during bariatric surgery. This trial will be conducted at one of the highest volume bariatric centers in Canada. This study also aims to examine the effects of deep neuromuscular blockade on patient-relevant outcomes, including postoperative pain and narcotic use. The investigators anticipate this study will facilitate the continual improvement of care provided to a growing number of bariatric patients.

Clinical Trial Description

This will be a double-blind randomized controlled trial comparing patients undergoing a deep neuromuscular blockade with a paralytic reversal agent versus patients undergoing standard anesthetic protocols in low-pressure pneumoperitoneum bariatric surgery. The study population will include patients aged 18-65 referred to St. Joseph's Healthcare for Roux-en-Y Gastric Bypass (RYGB) after completion of standard work-up for bariatric surgery through the Ontario Bariatric Network (OBN). The investigators plan to recruit and randomize 100 patients in a 1:1 ratio between deep NMB and standard anesthetic in low-pressure pneumoperitoneum bariatric surgery. Once enrolled in the study, patients will be assigned to one of the two groups using computer-based randomization on REDCap software. Allocation will be concealed until the time of the operation and will be provided directly to the anesthetist in opaque envelopes. The anesthetist will be aware of the assigned group, but the patient, surgeon, PACU nurses, ward nurses, research assistants and house staff will be blinded. The primary outcomes to be examined will include maximum intra-abdominal pressure, Leiden-Surgical Rating Scale, and postoperative pain scores. Secondary outcomes will include operative time, postoperative nausea, postoperative narcotic use, and length of stay. ;

Study Design

Related Conditions & MeSH terms

Bariatric Surgery

Clinical Trial Details

NCT number	NCT03803982
Study type	Interventional
Source	McMaster University
Contact	Dennis Hong, MD, MSc
Phone	905-522-1155
Email	dennishong70@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	January 2019
Completion date	December 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.