Comparison Of Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)

Phase 2

Completed

• Conditions: Neuromuscular Blockade

• Registration Number: NCT03532178
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2018-04-03
• Study First Submitted QC: 2018-05-09
• Study First Posted: 2018-05-22
• Study Start: 2019-01-01
• Primary Completion: 2022-03-31
• Study Completion: 2022-04-01
• Results First Submitted: 2023-07-03
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Results First Posted: 2023-09-08
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Eligible and scheduled for ECT
• Has the capacity to consent for the study

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Recovery Time of T1 to 90% Baseline	30 minutes	The time of neuromuscular recovery from sugammadex 4mg/kg dose reversal rocuronium at 0.6 mg/kg compared with traditionally used succinylcholine in electroconvulsive therapy (ECT).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Treatment or Emergent Adverse Events of the Drugs	24 hours after the procedure	To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population

Trial Locations

Locations (1)

UCSF Parnassus Campus; 🇺🇸 San Francisco, California, United States