Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery

Quantitative Neuromuscular Monitoring and Gastric Bypass Surgery
warningThe safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05886218
Recruitment Status : **RECRUITING NOW**

First Posted : June 2, 2023

Last Update Posted : June 2, 2023

Sponsor:

Information provided by (Responsible Party):

Neal Fleming, MD, PhD, University of California, Davis

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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.

SugammadexDevice: Quantitative Neuromuscular Function Monitoring

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Study Type :Observational
Estimated Enrollment :215 participants
Observational Model:Other
Time Perspective:Prospective
Official Title:A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery
Actual Study Start Date :February 8, 2023
Estimated Primary Completion Date :February 2024
Estimated Study Completion Date :July 2024
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Intervention Details:

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Primary Outcome Measures :

  1. Oxygen desaturation [ Time Frame: 24 hrs ]

    Incidence and magnitude of significant oxygen desaturation

Secondary Outcome Measures :

  1. The rate of compliance with muscle relaxant monitoring and reversal protocols [ Time Frame: 24 hrs ]

    Rate of compliance (%)

  2. Total intraoperative rocuronium use [ Time Frame: 24 hrs ]

    Total dose/kg/hr (mg/kg/hr)

  3. Total sugammadex dose [ Time Frame: 24 hrs ]

    Total dose (mg/kg)

  4. Post-operative supplemental oxygen requirement [ Time Frame: 24 hrs ]

    Oxygen requirement (FiO2%/hr)

  5. Post-operative unit length of stay [ Time Frame: 7 days ]

    Length of stay (Hours)

  6. Hospital Length of stay [ Time Frame: 7 days ]

    Length of stay (Hours)

  7. Success rate for wearable device [ Time Frame: 24 hrs ]

    Rate of compliance (%)

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Information from the National Library of Medicine NIH NLM ABRV BLK 4

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:  18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:  All
Sampling Method:  Probability Sample

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

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%)
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Information from the National Library of Medicine NIH NLM ABRV BLK 4

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05886218

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UC Davis Medical Center
Sacramento, California, United States, 95817
Contact: Ana Arias    916-703-5456    apaarias@ucdavis.edu   
Contact: Neal Fleming, MD, PhD    916 734-5046    nwfleming@ucdavis.edu   

University of California, Davis

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Responsible Party:Neal Fleming, MD, PhD, Clinical Professor, University of California, Davis
ClinicalTrials.gov Identifier:NCT05886218    
Other Study ID Numbers:2004503
First Posted:June 2, 2023    Key Record Dates
Last Update Posted:June 2, 2023
Last Verified:May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:No

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Studies a U.S. FDA-regulated Drug Product:No
Studies a U.S. FDA-regulated Device Product:No

Source: View full study details on ClinicalTrials.gov

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

June 3, 2023Comments OffClinicalTrials.gov | Gastroenterology Clinical Trials | Gastroenterology Studies | US National Library of Medicine
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