Neuromuscular Blocks
Conditions
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.
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 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.
Interventions
DRUG2 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.
DRUG0.07 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).
Sponsors
Merck Sharp & Dohme LLC
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
A single-center, Assessor-Blinded, parallel group randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactSabry Ayad, MD
Backup ContactErica Linna, RN
Outcome results
None listed