Cleveland Clinic Fairview Hospital
Cleveland, Ohio, 44111, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06136585
Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
2 mg/kg sugammadex
DrugAll 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.
0.07 mg/kg neostigmine
DrugAll 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).
Primary outcomes
-
Time required from reversal of neuromuscular block to discharge readiness
Time frame: 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 outcomes
-
Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.
Time frame: 2 hours of post anesthetic recovery
Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.
Study contacts
Contact information is provided by the study sponsor or research team.
Erica Linna, RN
CONTACT
Sabry Ayad, MD
CONTACT
Sponsors and collaborators
Lead sponsor
The Cleveland Clinic
Other
Collaborators
- Merck Sharp & Dohme LLC
Registry information
Official study 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
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Nov 18, 2023
- Registry last updated
- Dec 15, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.