At a glance
ClinicalIndex Comparison Record- ✓Age 18-80 years
- ✓Undergoing laparoscopic cholecystectomy
- ✓Anticipated surgical duration less than 2 hours
- ✓ASA physical status classification 1-3
- ✕Preoperative urinary catheter
- ✕History of problems with urination
- ✕Current use of anticholinergic medications (antihistamines, phenothiazines, antidepressants, antipsychotics)
- ✕Current UTI or urogenital problem (incontinence, bladder retention, prostate hypertrophy)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
In Brief
A Phase 4 clinical trial evaluating Neostigmine and Sugammadex for Urinary Retention Postoperative and 6 related conditions. Completed, enrolled 235 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, neostigmine.
Maintenance neuromuscular blockade with boluses of rocuronium. For reversal, sugammadex