Comparing sugammadex and neostigmine for reversing muscle relaxation during outpatient ERCP
Comparison of Efficacy of Sugammadex Versus Neostigmine in Reversing Neuromuscular Blocks in Patients Having Outpatient Endoscopic Retrograde Cholangiopancreatography (ERCP). A Randomized, Double-Blinded Trial
This study is testing whether sugammadex or neostigmine works better to reverse muscle relaxation in adults undergoing a specific outpatient procedure called ERCP.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06136585 on ClinicalTrials.gov |
What this trial studies
This trial aims to compare the effectiveness of two medications, sugammadex and neostigmine, in reversing muscle relaxation caused by rocuronium in patients undergoing outpatient endoscopic retrograde cholangiopancreatography (ERCP) at the Cleveland Clinic. It is a single-center, assessor-blinded, parallel group randomized trial involving 80 adult patients classified as ASA physical status 3 and 4. Participants will be randomly assigned to receive either sugammadex or neostigmine, with randomization stratified by age and type of procedure. The anesthesiologists will know the group assignments, but patients and outcome assessors will remain blinded.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with ASA physical status 3 or 4 scheduled for elective outpatient ERCP.
Not a fit: Patients with difficult airways, neuromuscular disorders, end-stage renal disease requiring dialysis, or those who are pregnant or breastfeeding will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and safer option for reversing neuromuscular blocks in patients undergoing outpatient procedures.
How similar studies have performed: Previous studies have shown varying success with similar approaches, but this specific comparison of sugammadex and neostigmine in the outpatient ERCP setting is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic Fairview Hospital — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ryu Komatsu, MD — The Cleveland Clinic
- Study coordinator: Sabry Ayad, MD
- Email: Saayad@ccf.org
- Phone: 216-476-7052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.