Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Bariatric Surgery
• Intervention / Treatment: Procedure: Deep Neuromuscular Blockade; Drug: Sugammadex

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep Neuromuscular Blockade, Sugammadex; All patients will receive anesthetic induction and maintenance as per routine using a combination of propofol, opioids, dexamethasone, and 0.6 mg/kg of rocuronium for induction. Patients will also receive lidocaine 1 mg/kg/hour IV infusion, followed by 3-5 mg of morphine equivalents prior to extubation. Patient monitoring will be according to local practice and consist of electrocardiography, blood pressure, heart rate and bispectral index monitoring. Neuromuscular function will be monitored every 20 minutes using a standardized nerve monitor. After induction and intubation, patients in the Deep Neuromuscular Blockade group (experimental group) will receive additional rocuronium to achieve a NMB blockade of TOF of 0 twitch and maintained at this level until reversal.	Procedure: Deep Neuromuscular Blockade; The proposed intervention in this study is delivery of an anesthetic with Deep Neuromuscular Blockage (NMB), which will be defined as a TOF of 0 and 2-3 twitches in the post-tetanic count.; Drug: Sugammadex; Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.
No Intervention: Standard Anesthetic; Patients in the standard anesthetic (or control group) will also receive anesthetic induction as per routine using a combination of propofol, opioids, dexamethasone, and rocuronium, with a lidocaine infusion. Patient monitoring will be similar to the experimental group, with electrocardiography, blood pressure, heart rate, and bispectral index monitoring. Patients in the control group will receive rocuronium 30 mg intravenous prior to intubation, followed by repeated 10 mg doses to reach a TOF of 1-2 twitches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum IAP	Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)	Intraoperatively
Leiden-Surgical Rating Scale	Assessment of operating conditions, as assessed by the surgeon, assessed at the beginning of each position change (supine and reverse Trendelenburg). Scale ranges from 1 (extremely poor operating conditions) to 5 (optimal conditions).	Intraoperatively
Postoperative Pain	Postoperative pain as reported by the patient. Pain will be assessed on post operative day 1 at 8 am, noon, and 8pm, and an average pain score will then be calculated for post operative day 1. Pain will be assessed on an 11-point scale ranging from 0 (no pain) to 10 (most pain imaginable)	Post Operative Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Time	Two operative times will be recorded. The first will be related strictly to the surgery, from time of Veress needle insertion to time of removal of the final port. In addition, total operative time will also be recorded which will include time of induction and reversal of anesthesia	Intraoperative
Postoperative Nausea	Postoperative nausea as reported by the patient	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).
Postoperative Narcotic Use	Amount of narcotic used by the patient postoperative	During index admission, up to one week.
Length of Stay	Length of stay	During index admission; through study completion, an average of 5 days

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Dennis Hong, MD, MSc, Centre for Minimal Access Surgery

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 11, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: low pressure pneumoperitoneum

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual Participant Data will not be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No