Phase 2
N=44
Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Neuromuscular Blockade
Bottom Line
View on ClinicalTrials.gov: NCT03532178 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Recovery Time of T1 to 90% Baseline — 6.79; 10.97 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline (Drug); Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex; (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recovery Time of T1 to 90% Baseline |
6.79; 10.97 | — |
| SECONDARY Number of Participants With Treatment or Emergent Adverse Events of the Drugs |
1; 3; 1; 2; 7; 9 | — |
Summary
The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT.
Eligibility Criteria
Inclusion Criteria
- Eligible and scheduled for ECT
- Has the capacity to consent for the study
Exclusion Criteria
- Any acute major organ failure in the last 30 days
- Any known or suspected neuromuscular disorders
- Any history of allergic reaction or intolerance to sugammadex, rocuronium, or succinylcholine
- Any conditions with severe renal impairment, including those requiring dialysis
- Anyone currently taking lithium
- Anyone currently taking hormonal contraceptives
- Anyone taking anti-coagulants, including vitamin K antagonists, unfractionated heparin, low molecular weight heparinoids, rivaroxaban, and dabigatran
Data sourced from ClinicalTrials.gov (NCT03532178). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.