Clinical trial NCT03803982: Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery
Official title: Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bariatric Surgery
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators propose to conduct a double-blind RCT comparing deep neuromuscular blockade to standard blockade during bariatric surgery. Participants will be randomized to one of the two groups in a 1:1 ratio.
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* The patient meets NIH criteria for bariatric surgery and has not received a previous bariatric surgical procedure
* The patient is aged 18-65 years and has completed the screening and preparation process prescribed by the Ontario Bariatric Network

Exclusion Criteria:

* Inability to give informed consent
* ASA \> 4
* Planned procedure other than RYGB or contraindications to RYGB
* BMI \> 55 kg/m2
* Revisional procedure
* Allergies or suspected allergies to anesthetic medications (rocuronium or sugammadex)
* Renal insufficiency (GFR \< 30ml/min)
* Family or personal history of malignant hyperthermia or personal history of neuromuscular disease
* History of chronic pain needing daily medications for the last \>3 months

Primary outcomes:
measure: Maximum IAP
timeFrame: Intraoperatively
measure: Leiden-Surgical Rating Scale
timeFrame: Intraoperatively
measure: Postoperative Pain
timeFrame: Post Operative Day 1
Secondary outcomes:
measure: Operative Time
timeFrame: Intraoperative
measure: Postoperative Nausea
timeFrame: Postoperative nausea scores will be recorded at 8 am, 2 pm, and 8pm on post operative day 1. Nausea will be measured on an 11-point scale ranging from 0 (no nausea) to 10 (most nausea imaginable).
measure: Postoperative Narcotic Use
timeFrame: During index admission, up to one week.
measure: Length of Stay
timeFrame: During index admission; through study completion, an average of 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Centre for Minimal Access Surgery
name: Dennis Hong, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: