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

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

Detailed Description
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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.

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

Conditions
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Neuromuscular Blockade

Intervention / Treatment
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* 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;


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>rocuronium + sugammadex / succinylcholine + normal saline | Drug: Group A. Muscle relaxant #1: rocuronium + sugammadex; Muscle relaxant #2: succinylcholine +saline<br>* 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.<br>* Other names: Rocuronium: Zemuron. Sugammadex: Bridion. Succinylcholine: Suxamethonium;|
| Experimental: Group B<br>succinylcholine + normal saline / rocuronium + sugammadex | Drug: Group B. Muscle relaxant #2: succinylcholine +saline; Muscle relaxant #1: rocuronium + sugammadex;<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery Time of T1 to 90% Baseline | 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). | 30 minutes | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroconvulsive Therapy, Neuromuscular Blockade