Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial

Part of paid clinical trials in Cleveland, Ohio.

Sponsor: The Cleveland Clinic
Study ID: NCT06136585
Phase: PHASE3
Status: Recruiting

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Conditions

Neuromuscular Blocks

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

2 mg/kg sugammadex — DRUG
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex.
0.07 mg/kg neostigmine — DRUG
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg).

Study Details

The investigators propose a single-center, assessor-Blinded, parallel group randomized trial to compare the efficacy of reversal of rocuronium induced neuromuscular blockade by sugammadex versus neostigmine in patients undergoing Endoscopic retrograde cholangiopancreatography at Cleveland Clinic Fairview Hospital.

Key Dates

Start date: Jun 1, 2024
Status verified: Dec 2025
Primary completion: Oct 31, 2026
Completion: Dec 31, 2026

Study Design

Enrollment: 80 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: 2 mg/kg sugammadex
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 2 mg/kg sugammadex.
Active Comparator: 0.07 mg/kg neostigmine
All participants will be given rocuromium for neuromuscular blocks during the procedure. Per randomization, patients in this group will be reversed with 0.07 mg/kg neostigmine (to a maximum of 5 mg).

Primary Outcome Measure

Time required from reversal of neuromuscular block to discharge readiness [ Time Frame: First 24 hours after reversal of neuromuscular block ]

Central Contacts

Sabry Ayad, MD
216-476-7052
[email protected]
Erica Linna, RN
216-633-5073
[email protected]

Locations (1)

Facility	City	State	ZIP	Site coordinators
Cleveland Clinic Fairview Hospital	Cleveland	Ohio	44111	Erica Linna, RN [email protected] 216-492-0186 Sabry Ayad, MD (PRINCIPAL_INVESTIGATOR)

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Cleveland Clinic Fairview Hospital· Cleveland, OH