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Completed

NCT Number: NCT03532178

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

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

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Key information

Conditions

Neuromuscular Blockade

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

UCSF Parnassus Campus

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline

Drug

The participants will be randomized to start with "Muscle relaxant #1" in the first study treatment, and will switch to "Muscle relaxant #2" in the second study treatment period.

Other names: Rocuronium: Zemuron. Sugammadex: Bridion. Succinylcholine: Suxamethonium

Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;

Drug

The participants will be randomized to start with "Muscle relaxant #2" in the first study treatment, and will switch to "Muscle relaxant #1" in the second study treatment period.

Primary outcomes

  1. Recovery Time of T1 to 90% Baseline

    Time frame: 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 outcomes

  1. Number of Participants With Treatment or Emergent Adverse Events of the Drugs

    Time frame: 24 hours after the procedure

    To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: CRoSSECT

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 22, 2018
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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