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

Sponsor

The Cleveland Clinic (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06136585

Collaborator

Merck Sharp & Dohme LLC (Industry)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

We 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 Main Campus.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Blocks	Drug: 2 mg/kg sugammadex Drug: 0.07 mg/kg neostigmine	N/A

Detailed Description

We 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 Main Campus 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

A single-center, Assessor-Blinded, parallel group randomized trial

Primary Purpose:

Treatment

Official Title:

Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Oct 31, 2025

Anticipated Study Completion Date :

Oct 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: 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. Other 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.
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).	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). Other Names: 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).

Arm

Intervention/Treatment

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.

Drug: 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.

Other 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.

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).

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).

Other Names:

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).

Outcome Measures

Primary Outcome Measures

Time required from reversal of neuromuscular block to discharge readiness [First 24 hours after reversal of neuromuscular block]
To assess the time required from reversal of neuromuscular block to discharge readiness in patients randomized to sugammadex or neostigmine.

Secondary Outcome Measures

Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine. [2 hours of post anesthetic recovery]
Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

The Cleveland Clinic
Merck Sharp & Dohme LLC

Investigators

Principal Investigator: Ryu Komatsu, MD, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ryu Komatsu, MD, The Cleveland Clinic

ClinicalTrials.gov Identifier:

NCT06136585

Other Study ID Numbers:

23-378

First Posted:

Nov 18, 2023

Last Update Posted:

Nov 18, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Neostigmine

Study Results

No Results Posted as of Nov 18, 2023