Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery

Sponsor

University of Missouri-Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05887375

Collaborator

Merck Sharp & Dohme LLC (Industry)

118

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spine Surgery Reversal of Neuromuscular Blockade Urinary Retention Postoperative	Drug: Sugammadex Drug: Neostigmine Drug: Glycopyrrolate Drug: Rocuronium	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

118 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Double-blind, Randomized, Parallel Group Study to Compare Rocuronium Reversal With Sugammadex (Bridion®) Versus Neostigmine/Glycopyrrolate and the Incidence of Urinary Retention After Elective Ambulatory Posterior Lumbar Laminectomy

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sugammadex 2 mg/kg Sugammadex 2 mg/kg administered as a single intravenous (IV) dose.	Drug: Sugammadex Sugammadex will be used to reverse rocuronium neuromuscular blockade (NMB). Dose will be according to participant actual body weight. Other Names: Bridion MK-8616 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. Other Names: Rocuronium Bromide
Active Comparator: 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.	Drug: Neostigmine Neostigmine will be used to reverse rocuronium NMB. Dose will be according to participant actual body weight. Other Names: Bloxiverz Drug: Glycopyrrolate Glycopyrrolate will be co-administered with neostigmine during reversal of rocuronium NMB. Dose will be according to participant actual body weight. Other Names: Glycopyrrolate injection, USP 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. Other Names: Rocuronium Bromide

Arm

Intervention/Treatment

Experimental: Sugammadex 2 mg/kg

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

Drug: Sugammadex

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

Other Names:

Bridion

MK-8616

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.

Other Names:

Rocuronium Bromide

Active Comparator: 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.

Drug: Neostigmine

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

Other Names:

Bloxiverz

Drug: Glycopyrrolate

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

Other Names:

Glycopyrrolate injection, USP

Drug: Rocuronium

Other Names:

Rocuronium Bromide

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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)