Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

NCT ID: NCT03803982

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2020-12-31

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.

Conditions

Bariatric Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Deep Neuromuscular Blockade

Intervention Type: PROCEDURE

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.

Sugammadex

Intervention Type: DRUG

Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Sugammadex

Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Dennis Hong MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dennis Hong, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre for Minimal Access Surgery

Central Contacts

Dennis Hong, MD, MSc

Role: CONTACT

dennishong70@gmail.com

905-522-1155 ext. 32938

Other Identifiers

low pressure pneumoperitoneum

Identifier Type: -

Identifier Source: org_study_id