Summary

for people ages 18 years and up (full criteria)
at San Francisco, California
study started
estimated completion:
Chanhung Lee

Description

Summary

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

Official Title

A Double-Blind, Randomized, Crossover Design Study To Compare The Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)

Details

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.

Keywords

Neuromuscular Blockade Electroconvulsive Therapy, Neuromuscular Blockade Rocuronium Succinylcholine Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Location

  • UCSF Parnassus Campus not yet accepting patients
    San Francisco California 94143 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT03532178
Phase
Phase 2
Lead Scientist
Chanhung Lee
Study Type
Interventional
Last Updated
May 9, 2018