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

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ClinicalTrials.gov Identifier: NCT03532178
Recruitment Status : Recruiting
First Posted : May 22, 2018
Last Update Posted : July 14, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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
Neuromuscular Blockade 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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : January 1, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

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Arms and Interventions
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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 Name: 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
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Incidence of treatment or emergent adverse events of the drugs [ Time Frame: Up to 24 hours ]
    To document the side-effect profiles of sugammadex reversal of rocuronium and succhinylcholine in the ECT patient population


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532178


Contacts
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Contact: Chanhung Lee, MD, PHD 415-206-8906 Chanhung.lee@ucsf.edu

Locations
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United States, California
UCSF Parnassus Campus Recruiting
San Francisco, California, United States, 94143
Contact: Chanhung Lee, MD, PhD    415-206-8906    Chanhung.lee@ucsf.edu   
Sponsors and Collaborators
University of California, San Francisco
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Chanhung Lee, MD, PhD University of California, San Francisco
More Information
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Publications of Results:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03532178    
Other Study ID Numbers: MISP#56343
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: July 14, 2020
Last Verified: July 2020

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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:
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Rocuronium
Succinylcholine
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neuromuscular Depolarizing Agents