Clinical trial NCT06136585: Sugammadex Vs Neostigmine in Reversing Neuromuscular Blocks in Outpatient ERCP. A Randomized, Double-Blinded Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuromuscular Blocks
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2023-11-18
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Main Campus.

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 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.

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

Primary outcomes:
measure: Time required from reversal of neuromuscular block to discharge readiness
timeFrame: First 24 hours after reversal of neuromuscular block
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting (PONV) in patients randomized to sugammadex or neostigmine.
timeFrame: 2 hours of post anesthetic recovery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Ryu Komatsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.