NCT05886218

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
215

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 8, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 15, 2025

Status Verified

November 1, 2024

Enrollment Period

2.4 years

First QC Date

May 23, 2023

Last Update Submit

May 13, 2025

Conditions

Sugammadex

Outcome Measures

Primary Outcomes (1)

  • Oxygen desaturation

    Incidence and magnitude of significant oxygen desaturation

    24 hours

Secondary Outcomes (7)

  • The rate of compliance with muscle relaxant monitoring and reversal protocols

    24 hours

  • Total intraoperative rocuronium use

    24 hours

  • Total sugammadex dose

    24 hours

  • Post-operative supplemental oxygen requirement

    24 hours

  • Post-operative unit length of stay

    7 days

  • +2 more secondary outcomes

Interventions

Quantitative Neuromuscular Function MonitoringDEVICE

Quantitative electromyographic (EMG) monitoring

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

Central Study Contacts

Ana P Arias, BS

CONTACT

916-703-5456apaarias@ucdavis.edu

Julio J Arana Pineda, BA

CONTACT

916-734-4074jjaranapineda@ucdavis.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2023

First Posted

June 2, 2023

Study Start

February 8, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 15, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)