Title

Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)
Optimal Control of Muscle Strength for Electroconvulsive Therapy: A Comparison of Succinylcholine Versus Rocuronium-induced Neuromuscular Blockade
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    45
Electroconvulsive therapy (ECT) is the transcutaneous application of small electrical stimuli to the brain to produce generalized seizures for the treatment of selected psychiatric disorders such as severe depression. The aim of ECT is to induce a therapeutic tonic seizure where the person loses consciousness and has convulsions. Patients need general anesthesia and neuromuscular blockade to treat pain and avoid excessive tonic clonic motor contraction that might be associated with compression fractures. Neuromuscular blocking drugs (NMBD) are, therefore, administered after induction of general anesthesia to induce neuromuscular blockade. Despite the importance of NMBDs to provide optimal conditions for ECT treatment, the optimal NMBD dose to achieve acceptable neuromuscular blockade without excessive or untoward effects has not previously been identified in any study and in a prospective randomized fashion. The aim of this study is, therefore, to identify the optimal NMBD dose of two commonly used neuromuscular blocking agents (succinylcholine and rocuronium) in order to optimize the muscle strength modulation during ECT that facilitates ECT with the minimal side effects.
Patients, who consent to participate in the study, will randomly receive either succinylcholine or rocuronium by utilizing the Dixon's up and down technique. For patient safety, the first dose of either agent will be defined by the anesthesiologist providing care, and subsequent doses will be incrementally increased or decreased by 10% based on the assessment of a psychiatrist blinded to dose, who uses a dichotomous scale to assess the quality of the ECT (acceptable and not acceptable). The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.

Acceleromyography will be used for monitoring neuromuscular transmission. Following induction of general anesthesia, the TOF-Watch SX will be calibrated (mode 1, 50 mA), and train-of-four (TOF) stimulation (every 15 seconds) will be initiated and maintained until recovery of the T1 to 100% baseline. Non-invasive blood pressure, heart rate, peripheral oxygen saturation (SpO2), and time to recovery of spontaneous breathing will be measured during the procedure. In addition the investigators will measure stimulation parameters used to initiate ECT, as well as the duration of seizure as well as the entire procedure time.
Study Started
May 31
2011
Primary Completion
Jul 31
2013
Study Completion
Feb 28
2015
Results Posted
Jun 02
2015
Estimate
Last Update
Jun 02
2015
Estimate

Drug Succinylcholine

Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.

  • Other names: Suxamethonium

Drug Rocuronium

Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.

Succinylcholine first, then Rocuronium Experimental

Cross-over randomized controlled, assessor blinded clinical trial.

Rocuronium first, then succinylcholine Experimental

Cross-over randomized controlled, assessor blinded clinical trial.

Criteria

Inclusion Criteria:

Adult patients (age 18-80) scheduled for ECT treatment at the MGH

Exclusion Criteria:

Contraindication to the use of neuromuscular blocking drugs (e.g. allergy, preexisting muscular disease, and history of malignant hyperthermia)
Malnutrition, general weakness
Neurological or neuromuscular disease, including paralysis
Liver disease with liver function test 2x greater than upper normal limit
Kidney disease with eGFR<60
Electrolyte abnormalities with values outside of the normal range
Pregnancy
Cardiac disease or abnormal EKG
Medications that affect seizure threshold or blood pressure response
Unwilling to participate in the study

Summary

NMBA: Succinylcholine

NMBA: Rocuronium

All Events

Event Type Organ System Event Term

Optimal Dose of Neuromuscular Blocking Agent During ECT

The optimal dose of muscle neuromuscular blocking is defined as the lowest dose of either compound that predicts 'acceptable' control of muscle strength during ECT. Assessment of the primary end point is based on a dichotomous scale 'acceptable' and 'not acceptable' control of muscle strength during ECT, and the two assessors will be blinded to the dose of neuromuscular blocking agent. The optimal dose was identified for each subject, and results were reported as the average of all lowest doses collected in the study.

NMBA: Sux

0.85
mg.kg-1 (Mean)
95% Confidence Interval: 0.77 to 0.94

NMBA- Rocuronium

0.41
mg.kg-1 (Mean)
95% Confidence Interval: 0.36 to 0.46

Compound Specific Differences in Time to Recovery From Neuromuscular Blockade

The investigators defined the compound specific differences in time to recovery from neuromuscular blockade - i.e., recovery of spontaneous breathing and recovery of the twitch height to baseline.

Succinylchline

9.7
minutes (Mean)
Standard Deviation: 3.5

Rocuronium

19.5
minutes (Mean)
Standard Deviation: 5.7

Differences in Seizure Duration Between Compounds

Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.

Succinylcholine

27.0
Seconds (Mean)
Standard Deviation: 14

Rocuronium

31.0
Seconds (Mean)
Standard Deviation: 11

Age, Continuous

52
Years (Mean)
Standard Deviation: 8

Age, Categorical

Region of Enrollment

Sex: Female, Male

First Neuromuscular Blocking Agent:

Succinylcholine First, Then Rocuronium

Rocuronium First , Then Succinylcholine

Second Neuromuscular Blocking Agent

Succinylcholine First, Then Rocuronium

Rocuronium First , Then Succinylcholine

Drop/Withdrawal Reasons

Succinylcholine First, Then Rocuronium

Rocuronium First , Then Succinylcholine