Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

NCT03803982 | Unknown DMC

• 1 other identifier: low pressure pneumoperitoneum
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bariatric Surgery

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Operative Time

  Intraoperative

• Postoperative Nausea

  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

  During index admission, up to one week.

• Length of Stay

  During index admission; through study completion, an average of 5 days

Study Arms (2)

Deep Neuromuscular Blockade, Sugammadex

EXPERIMENTAL

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; Drug: Sugammadex

Standard Anesthetic

NO INTERVENTION

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.

Interventions

Deep Neuromuscular Blockade 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.

Deep Neuromuscular Blockade, Sugammadex

Sugammadex DRUG

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

Deep Neuromuscular Blockade, Sugammadex

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Dennis Hong, MD, MSc

  Centre for Minimal Access Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dennis Hong, MD, MSc

CONTACT

905-522-1155; dennishong70@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients, surgeons, ward and PACU nurses, research assistants, and surgical house-staff will be blinded to the randomization. The anesthesiologist will be aware of the randomization as this will directly impact the anesthetic delivered to the patients.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 15, 2019
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: January 15, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share