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

Sponsor
University of California, San Francisco (Other)
Overall Status
Unknown status
CT.gov ID
NCT03532178
Collaborator
Merck Sharp & Dohme LLC (Industry)
50
Enrollment
1
Location
2
Arms
35
Anticipated Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Group A. "Muscle relaxant #1": rocuronium + sugammadex; "Muscle relaxant #2": succinylcholine +saline
  • Drug: Group B. "Muscle relaxant #2": succinylcholine +saline; "Muscle relaxant #1": rocuronium + sugammadex;
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
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.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
Official Title:
A Double-Blind, Randomized, Crossover Design Study To Compare The Rocuronium Reversal By Sugammadex To Succinylcholine For Electroconvulsive Therapy (ECT)
Actual Study Start Date :
Jan 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A

rocuronium + sugammadex / succinylcholine + normal saline

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

    		•
    Experimental: Group B

    succinylcholine + normal saline / rocuronium + sugammadex

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Incidence of treatment or emergent adverse events of the drugs [Up to 24 hours]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCSF Parnassus Campus San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • Merck Sharp & Dohme LLC

    Investigators

    • Principal Investigator: Chanhung Lee, MD, PhD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03532178
    Other Study ID Numbers:
    • MISP#56343
    First Posted:
    May 22, 2018
    Last Update Posted:
    Jul 14, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of California, San Francisco
    Electroconvulsive Therapy, Neuromuscular Blockade
    Additional relevant MeSH terms:
    Rocuronium
    Succinylcholine

    Study Results

    No Results Posted as of Jul 14, 2020