Trials / Completed
CompletedNCT05794503
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 235 (actual)
- Sponsor
- University of Texas Southwestern Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
This study is intended to be a single-site, prospective, randomized, controlled study that intends to enroll a total of 230 patients undergoing laparoscopic cholecystectomy at Parkland Hospital. Patients will be randomized to receive either neostigmine or sugammadex for reversal of rocuronium-induced neuromuscular blockade. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care. To account for protocol deviations and patient dropout, up to 250 randomization envelopes will be made and enrollment will continue until there are 230 completed enrollments.
Detailed description
Objective: To determine the incidence of postoperative urinary retention after reversal of rocuronium-induced neuromuscular blockade by neostigmine versus sugammadex in patients undergoing laparoscopic cholecystectomy. Hypothesis: Subjects who are reversed with sugammadex will have less postoperative urinary retention compared to subjects who are reversed with neostigmine.
Conditions
- Urinary Retention Postoperative
- Laparoscopic Cholecystectomy
- Neuromuscular Blockade
- Sugammadex
- Neostigmine
- Neuromuscular Blocking Agents
- Physiological Effects of Drugs
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Neostigmine | Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine. |
| DRUG | Sugammadex | Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex |
Timeline
- Start date
- 2023-09-11
- Primary completion
- 2024-06-30
- Completion
- 2024-06-30
- First posted
- 2023-04-03
- Last updated
- 2024-10-09
- Results posted
- 2024-10-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05794503. Inclusion in this directory is not an endorsement.