Sugammadex Clinical Trial
Official title:
A Before/After Study of the Impact of Quantitative Neuromuscular Monitoring and Sugammadex Reversal Following Gastric Bypass Surgery
| NCT number | NCT05886218 |
| Other study ID # | 2004503 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 8, 2023 |
| Est. completion date | July 2024 |
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.
| Status | Recruiting |
| Enrollment | 215 |
| Est. completion date | July 2024 |
| Est. primary completion date | February 2024 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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%) |
| Country | Name | City | State |
|---|---|---|---|
| United States | UC Davis Medical Center | Sacramento | California |
| Lead Sponsor | Collaborator |
|---|---|
| University of California, Davis |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Oxygen desaturation | Incidence and magnitude of significant oxygen desaturation | 24 hours | |
| Secondary | The rate of compliance with muscle relaxant monitoring and reversal protocols | Rate of compliance (%) | 24 hours | |
| Secondary | Total intraoperative rocuronium use | Total dose/kg/hr (mg/kg/hr) | 24 hours | |
| Secondary | Total sugammadex dose | Total dose (mg/kg) | 24 hours | |
| Secondary | Post-operative supplemental oxygen requirement | Oxygen requirement (FiO2%/hr) | 24 hours | |
| Secondary | Post-operative unit length of stay | Length of stay (Hours) | 7 days | |
| Secondary | Hospital Length of stay | Length of stay (Hours) | 7 days | |
| Secondary | Success rate for wearable device | Rate of compliance (%) | 24 hours |
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