Recruiting
Phase 3

Sugammadex vs. Neostigmine

Sponsor:

The Cleveland Clinic

Code:

NCT06136585

Conditions

Neuromuscular Blocks

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

2 mg/kg sugammadex

0.07 mg/kg neostigmine

Study Details

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.

Conditions

Neuromuscular Blocks

Study ID

NCT06136585

Start date

Jun 1, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

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.

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 and Locations

Central contacts

Sabry Ayad, MD

216-476-7052Saayad@ccf.org

Erica Linna, RN

216-633-5073Linnae@ccf.org

Locations

Cleveland Clinic Fairview Hospital

Recruiting

Cleveland, Ohio, United States, 44111

Contacts

Erica Linna, RN

216-492-0186Linnae@ccf.org

Principal Investigator:

Sabry Ayad, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

Dec 15, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2025-12-15.