Deep Neuromuscular Relaxation Optimizing Low-Pressure Bariatric Surgery

January 11, 2019 updated by: Dennis Hong MD, McMaster University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum IAP
Time Frame: Intraoperatively
Maximum Intra-Abdominal Pressure, as assessed by the degree of pneumoperitoneum for each position (supine and reverse Trendelenburg)
Intraoperatively
Leiden-Surgical Rating Scale
Time Frame: Intraoperatively
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
Time Frame: Post Operative Day 1
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative Time
Time Frame: Intraoperative
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
Time Frame: 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 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
Time Frame: During index admission, up to one week.
Amount of narcotic used by the patient postoperative
During index admission, up to one week.
Length of Stay
Time Frame: During index admission; through study completion, an average of 5 days
Length of stay
During index admission; through study completion, an average of 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McMaster University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dennis Hong, MD, MSc, Centre for Minimal Access Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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