Clinical trial

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

Name

2096001

Description

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.

Trial arms

Trial start

2023-08-03

Estimated PCD

2024-08-01

Trial end

2024-09-01

Phase

Early phase I

Treatment

Sugammadex

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

Arms:

Sugammadex 2 mg/kg

Other names:

Bridion, MK-8616

Neostigmine

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

Arms:

Neostigmine + Glycopyrrolate

Other names:

Bloxiverz

Glycopyrrolate

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

Arms:

Neostigmine + Glycopyrrolate

Other names:

Glycopyrrolate injection, USP

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.

Arms:

Neostigmine + Glycopyrrolate, Sugammadex 2 mg/kg

Other names:

Rocuronium Bromide

Size

118

Primary endpoint

Incidence of urinary retention

Up to 6 hours after administration of study intervention

Eligibility criteria

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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 118, 'type': 'ESTIMATED'}}

Updated at

2023-09-29

1 organization

4 products

3 indications

Organization

University of Missouri-Columbia

Product

Sugammadex

Indication

Spinal Surgery

Indication