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NCT06136585PHASE3Recruiting

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

The Cleveland Clinic

Start Date

6/1/2024

Completion Date

12/31/2026

Summary

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.

Detailed Description

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. Participating patients and outcome assessors will be blinded to group assignment. The anesthesiologists who assume anesthesia care will not be blinded to group assignment. American Society of Anesthesiologists (ASA) physical status 3 and 4 adults scheduled for elective outpatient ERCP procedure with general anesthesia at Cleveland Clinic Fairview Hospital will be included in the study. Patients will be excluded if they have suspected difficult airway, neuromuscular disorders, end-stage renal disease requiring hemodialysis, are allergic to fentanyl, neuromuscular blocking drugs or neuromuscular reversal drugs, or are pregnant or breastfeeding. Eighty patients scheduled for outpatient ERCP with general anesthesia and rocuronium-induced muscle relaxation will be randomized 1:1 to: 1) reversal by sugammadex; or 2) reversal by neostigmine. Randomization will be stratified by 2 factors: (1) patient's age (older than 60 versus younger than 60) and (2) diagnostic vs. interventional procedures. Randomization will be based on computer generated codes that will be maintained in web-based system until shortly before induction of anesthesia, thus concealing allocation so long as practical.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * ≥18 years old * American Society of Anesthesiologist physical status 3-4 * Scheduled for outpatient endoscopic retrograde cholangiopancreatography Exclusion Criteria: * Difficult Airway * Neuromuscular Disorders (eg: ALS, Botulism, Myasthenia Gravis, Lambert-eaton syndrome) * End stage renal disease requiring dialysis * Pregnancy or breast-feeding * Allergy to Fentanyl * Allergy to Neuromuscular blocking drugs (eg: rocuronium) * Allergy to Neuromuscular reversal drugs (eg: sugammadex or neostigmine) * Allergy to glycopyrrolate

Interventions

DRUG

2 mg/kg sugammadex

DRUG

0.07 mg/kg neostigmine

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Conditions

Neuromuscular Blocks

Locations

Cleveland Clinic Fairview Hospital

Cleveland, Ohio 44111

United States