Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery

June 5, 2023 updated by: Neal Fleming, MD, PhD, University of California, Davis

A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery

This is a single site, prospective, non-blinded, non-randomized, before/after study. This study is designed to evaluate the impact of monitoring and reversal guidelines for neuromuscular blocking drugs on the post-operative outcomes for patients undergoing laparoscopic gastric bypass surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

215

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 Backup

Study Locations

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients scheduled for surgical procedures in the UC Davis Medical Center main ORs will be screened for potential enrollment.

Description

Inclusion Criteria:

  • age greater than 18 years
  • scheduled for an elective laparoscopic gastric bypass procedure

Exclusion Criteria:

  • age less than 18 years
  • pregnancy
  • prisoners
  • significant co-existing lung disease including asthma or chronic obstructive pulmonary disease (COPD) requiring regular medication
  • patients who require supplemental oxygen pre-operatively to maintain a hemoglobin saturation (SpO2>98%)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen desaturation
Time Frame: 24 hours
Incidence and magnitude of significant oxygen desaturation
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative unit length of stay
Time Frame: 7 days
Length of stay (Hours)
7 days
Hospital Length of stay
Time Frame: 7 days
Length of stay (Hours)
7 days
The rate of compliance with muscle relaxant monitoring and reversal protocols
Time Frame: 24 hours
Rate of compliance (%)
24 hours
Total intraoperative rocuronium use
Time Frame: 24 hours
Total dose/kg/hr (mg/kg/hr)
24 hours
Total sugammadex dose
Time Frame: 24 hours
Total dose (mg/kg)
24 hours
Post-operative supplemental oxygen requirement
Time Frame: 24 hours
Oxygen requirement (FiO2%/hr)
24 hours
Success rate for wearable device
Time Frame: 24 hours
Rate of compliance (%)
24 hours

Collaborators and Investigators

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

Sponsor

University of California, Davis

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 (Actual)

February 8, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

May 23, 2023

First Submitted That Met QC Criteria

May 23, 2023

First Posted (Actual)

June 2, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

June 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2004503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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