Clinical trial NCT03532178: Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Official title: A Double-Blind, Randomized, Crossover Design Study To Compare The Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuromuscular Blockade
Keywords: Electroconvulsive Therapy, Neuromuscular Blockade
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2018-05-22
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: The investigators propose to compare the recovery of neuromuscular blockade from rocuronium reversal by sugammadex to succinylcholine in ECT.

Detailed 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 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.

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

Primary outcomes:
measure: Recovery Time of T1 to 90% Baseline
timeFrame: 30 minutes
Secondary outcomes:
measure: Number of Participants With Treatment or Emergent Adverse Events of the Drugs
timeFrame: 24 hours after the procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Parnassus Campus
state: California
Study officials:
affiliation: University of California, San Francisco
name: Chanhung Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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