Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-03

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Spine Surgery Reversal of Neuromuscular Blockade Urinary Retention Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sugammadex 2 mg/kg

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

Group Type EXPERIMENTAL

Sugammadex

Intervention Type DRUG

Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.

Rocuronium

Intervention Type DRUG

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.

Neostigmine + 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.

Group Type ACTIVE_COMPARATOR

Neostigmine

Intervention Type DRUG

Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.

Glycopyrrolate

Intervention Type DRUG

Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.

Rocuronium

Intervention Type DRUG

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.

Interventions

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Sugammadex

Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight.

Intervention Type DRUG

Neostigmine

Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight.

Intervention Type DRUG

Glycopyrrolate

Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight.

Intervention Type DRUG

Rocuronium

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.

Intervention Type DRUG

Other Intervention Names

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Bridion MK-8616 Bloxiverz Glycopyrrolate injection, USP Rocuronium Bromide

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No