UC Davis Medical Center
Sacramento, California, 95817, United States
Location status: Recruiting
Location contact
Ana Arias
CONTACT
Neal Fleming, MD, PhD
CONTACT
Recruiting
NCT Number: NCT05886218
Quantitative Neuromuscular Monitoring and 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Only the study team can determine whether someone qualifies for participation.
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%)
Treatment and study plan
Quantitative Neuromuscular Function Monitoring
DeviceQuantitative electromyographic (EMG) monitoring
Primary outcomes
-
Oxygen desaturation
Time frame: 24 hours
Incidence and magnitude of significant oxygen desaturation
Secondary outcomes
-
The rate of compliance with muscle relaxant monitoring and reversal protocols
Time frame: 24 hours
Rate of compliance (%)
-
Total intraoperative rocuronium use
Time frame: 24 hours
Total dose/kg/hr (mg/kg/hr)
-
Total sugammadex dose
Time frame: 24 hours
Total dose (mg/kg)
-
Post-operative supplemental oxygen requirement
Time frame: 24 hours
Oxygen requirement (FiO2%/hr)
-
Post-operative unit length of stay
Time frame: 7 days
Length of stay (Hours)
-
Hospital Length of stay
Time frame: 7 days
Length of stay (Hours)
-
Success rate for wearable device
Time frame: 24 hours
Rate of compliance (%)
Study contacts
Contact information is provided by the study sponsor or research team.
Ana P Arias, BS
CONTACT
Julio J Arana Pineda, BA
CONTACT
Sponsors and collaborators
Lead sponsor
University of California, Davis
Other
Registry information
Official study title
A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Jun 2, 2023
- Registry last updated
- May 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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