Sugammadex Vs Neostigmine/glycopyrrolate on Urinary Retention After Spine Surgery

University of Missouri (MU)

Status and phase: Invitation-only; Phase 4

Conditions: Urinary Retention Postoperative; Spine Surgery; Reversal of Neuromuscular Blockade

Treatments: Drug: Sugammadex; Drug: Rocuronium; Drug: Glycopyrrolate; Drug: Neostigmine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05887375

MISP Database number 101357 (Other Identifier)

2096001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups

Sugammadex 2 mg/kg

Experimental group

Description:

Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Neostigmine + Glycopyrrolate

Active Comparator group

Description:

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.

Treatment:

Drug: Neostigmine

Drug: Glycopyrrolate

Drug: Rocuronium