Reversal of Neuromuscular Blockade, Spine Surgery, Urinary Retention Postoperative
Conditions
Keywords
Urinary retention, Spine surgery, Sugammadex, Neostigmine, Neuromuscular blockade, Neuromuscular blockade reversal, Cholinesterase Inhibitors, Cholinergic Agents, Physiological Effects of Drugs, Parasympathomimetic, Autonomic Agents
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.
Interventions
DRUGSugammadex
Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.
DRUGNeostigmine
Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.
DRUGGlycopyrrolate
Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.
DRUGRocuronium
To achieve NMB, participants will receive the steroidal neuromuscular blocking agent Rocuronium Bromide administered via IV infusion and dosed according to participant actual body weight. It will be used per label to maintain muscle relaxation as an adjunct to general anesthesia.
Sponsors
University of Missouri-Columbia
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBoris Mraovic, MD, FASA
University of Missouri-Columbia
Outcome results
None listed