Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)
Information source: Massachusetts General Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuromuscular Blockade; ECT
Intervention: Succinylcholine (Drug); Rocuronium (Drug)
Sponsored by: Massachusetts General Hospital
Official(s) and/or principal investigator(s):
Matthias Eikermann, MD, PhD, Principal Investigator, Affiliation: Massachusetts General Hospital
Ala Nozari, MD, PhD, Principal Investigator, Affiliation: Mass General Hospital
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.
Official title: Optimal Control of Muscle Strength for Electroconvulsive Therapy: A Comparison of Succinylcholine Versus Rocuronium-induced Neuromuscular Blockade
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Optimal Dose of Neuromuscular Blocking Agent During ECT
Compound Specific Differences in Time to Recovery From Neuromuscular Blockade
Differences in Seizure Duration Between Compounds
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
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.
Minimum age: 18 Years.
Maximum age: 80 Years.
- Adult patients (age 18-80) scheduled for ECT treatment at the MGH
- 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
- Cardiac disease or abnormal EKG
- Medications that affect seizure threshold or blood pressure response
- Unwilling to participate in the study
Locations and Contacts
Massachusetts General Hospital, Boston, Massachusetts 02114, United States
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Starting date: May 2011
Last updated: June 1, 2015