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

NCT ID: NCT06136585

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Neuromuscular Blocks

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

2 mg/kg sugammadex

Intervention Type: 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

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).

Group Type: ACTIVE_COMPARATOR

0.07 mg/kg neostigmine

Intervention Type: 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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

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.; 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).

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ryu Komatsu

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ryu Komatsu, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Fairview Hospital

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sabry Ayad, MD

Role: CONTACT

Saayad@ccf.org

216-476-7052

Erica Linna, RN

Role: CONTACT

Linnae@ccf.org

216-633-5073

Facility Contacts

Erica Linna, RN

Role: primary

Linnae@ccf.org

216-492-0186

References

Cotton PB. Are low-volume ERCPists a problem in the United States? A plea to examine and improve ERCP practice-NOW. Gastrointest Endosc. 2011 Jul;74(1):161-6. doi: 10.1016/j.gie.2011.03.1233. No abstract available.

Reference Type: BACKGROUND

PMID: 21704815 (View on PubMed)

Other Identifiers

23-378

Identifier Type: -

Identifier Source: org_study_id