Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery (NCT05887375) | Clinical Trial Compass
CompletedPhase 4
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
United States118 participantsStarted 2023-08-03
Plain-language summary
This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory spine surgery.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Age ≥ 18 years
* ASA Physical Status I-III
Exclusion Criteria:
* Inability to obtain written informed consent
* Allergy to medications used in the protocol
* Known or suspected neuromuscular disorders
* Significant renal disease with a serum creatinine ≥ 2 mg/dL
* Significant liver disease
* A family history of malignant hyperthermia
* History of genitourinary surgery, cancer, or radiation within the last year
* Currently prescribed urological medications or diuretics
* BPH or symptoms of BPH (interrupted or weak urine stream or wake up to urinate more than two times per night)
* History or diagnosis of urinary incontinence or urinary retention
* History of PONV with use of scopolamine
* Use of Foley catheter pre- or intra- operatively
* Perioperative medications that influence micturition (e.g., diuretics or intraoperative anticholinergic medication use other than NMB reversal)
What they're measuring
1
Incidence of urinary retention
Timeframe: Up to 6 hours after administration of study intervention