Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Neuromuscular Blockade
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentIntervention Model Description: The participants will be randomized to one of the two drug groups to start with, and will switch to the other group for the next treatment period. For the study, each participant will take two treatments in a random order: (1) rocuronium to be reversed by sugammadex, and (2) succinylcholine plus normal saline placebo.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: The randomization of treatment groups will be blinded to the patients themselves, the psychiatrists and outcome assessors, except the anesthesiologists who will administer the drugs.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The proposed study is a single center, randomized, double-blind (patients, psychiatrists and outcome assessor), cross-over clinical trial comparing the recovery of neuromuscular blockade from rocuronium with reversal of sugammadex to succinylcholine in participants receiving ECT. The primary outcome...
The proposed study is a single center, randomized, double-blind (patients, psychiatrists and outcome assessor), cross-over clinical trial comparing the recovery of neuromuscular blockade from rocuronium with reversal of sugammadex to succinylcholine in participants receiving ECT. The primary outcome will be the measurement of time when the first train-of-four (TOF) twitch (T1) returns to 90% of baseline. The secondary aims are to document the safety (adverse event rates) of rocuronium/sugammadex compared to succinylcholine in ECT patients. The exploratory aims are to establish the perioperative efficacy and efficiency of sugammadex reversal of rocuronium in ECT procedures in comparison with succinylcholine.
Tracking Information
- NCT #
- NCT03532178
- Collaborators
- Merck Sharp & Dohme Corp.
- Investigators
- Principal Investigator: Chanhung Lee, MD, PhD University of California, San Francisco
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