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

NeuroTherapia, Inc.

Status and phase: Enrolling; Phase 3

Conditions: Neuromuscular Blocks

Treatments: Drug: 2 mg/kg sugammadex; Drug: 0.07 mg/kg neostigmine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06136585

23-378

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

2 mg/kg sugammadex

Experimental group

Description:

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.

Treatment:

Drug: 2 mg/kg sugammadex

0.07 mg/kg neostigmine

Active Comparator group

Description:

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).

Treatment:

Drug: 0.07 mg/kg neostigmine