Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
- Conditions
- Spine SurgeryReversal of Neuromuscular BlockadeUrinary Retention Postoperative
- Interventions
- Registration Number
- NCT05887375
- Lead Sponsor
- University of Missouri-Columbia
- Brief 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.
- Detailed Description
Subjects requiring elective ambulatory posterior lumbar laminectomy, will receive either an intravenous infusion bolus of Sugammadex (2 mg/kg dosed by actual body weight) or intravenous infusion bolus of Neostigmine (50 μg/kg, up to 5 mg maximum dose) plus Glycopyrrolate (10 μg/kg, up to 1 mg maximum dose). Additionally, all subjects will receive hospital standard of care therapy for their surgery and hospital stay.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 118
- Age ≥ 18 years
- ASA Physical Status I-III
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sugammadex 2 mg/kg Rocuronium Sugammadex 2 mg/kg administered as a single intravenous (IV) dose. Sugammadex 2 mg/kg Sugammadex Sugammadex 2 mg/kg administered as a single intravenous (IV) dose. Neostigmine + Glycopyrrolate Neostigmine Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose. Neostigmine + Glycopyrrolate Rocuronium Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose. Neostigmine + Glycopyrrolate Glycopyrrolate Neostigmine 50 μg/kg (up to 5 mg maximum dose) plus glycopyrrolate 10 μg/kg (up to 1 mg maximum dose) administered as a single IV dose.
- Primary Outcome Measures
Name Time Method Incidence of urinary retention Up to 6 hours after administration of study intervention The difference between sugammadex and neostigmine/glycopyrrolate on the incidence of urinary retention defined as no void more than 6 hours after posterior lumbar spine surgery in ambulatory/short stay patients.
- Secondary Outcome Measures
Name Time Method Micturition Up to 1 day after administration of study intervention Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare actual times of micturition we will analyze the proportion of patients (percentages) voided at 6, 9, 12 and 24 hours.
Length of hospital stay Up to 7 Days after administration of study intervention Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare length of hospital stay.
Urinary retention symptoms Up to 1 day after administration of study intervention Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare urinary retention symptoms, we will administer a questionnaire at 6 hours postoperatively and on postoperative day 1.
Bladder catheterization Up to 1 Day after administration of study intervention Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare need for bladder catheterization (straight or Foley).
Bladder urine volume Up to 6 hours after administration of study intervention Between patients who received sugammadex and neostigmine/glycopyrrolate. To compare bladder urine volumes in milliliters (mL) we will perform bladder ultrasound scan at 6 hours postoperatively if patients did not void.
Trial Locations
- Locations (1)
University Hospital
🇺🇸Columbia, Missouri, United States