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The 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 |
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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
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.
| Sugammadex | Device: Quantitative Neuromuscular Function Monitoring |
| 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 |
- Oxygen desaturation [ Time Frame: 24 hrs ]
Incidence and magnitude of significant oxygen desaturation
- The rate of compliance with muscle relaxant monitoring and reversal protocols [ Time Frame: 24 hrs ]
Rate of compliance (%)
- Total intraoperative rocuronium use [ Time Frame: 24 hrs ]
Total dose/kg/hr (mg/kg/hr)
- Total sugammadex dose [ Time Frame: 24 hrs ]
Total dose (mg/kg)
- Post-operative supplemental oxygen requirement [ Time Frame: 24 hrs ]
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 hrs ]
Rate of compliance (%)
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.
| Ages Eligible for Study:  | 18 Years and older  (Adult, Older Adult) |
| Sexes Eligible for Study: Â | All |
| Sampling Method: Â | 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%)
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
| 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
| Responsible Party: | Neal Fleming, MD, PhD, Clinical Professor, University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT05886218 Â Â |
| Other Study ID Numbers: | 2004503 |
| First Posted: | June 2, 2023 Â Â Key Record Dates |
| Last Update Posted: | June 2, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| 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.
