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Optimal Dose of Succinylcholine and Rocuronium for Electroconvulsive Therapy (ECT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ala Nozari, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01441960
First received: September 20, 2011
Last updated: July 6, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Neuromuscular Blockade
ECT
Drug: Succinylcholine
Drug: Rocuronium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimal Control of Muscle Strength for Electroconvulsive Therapy: A Comparison of Succinylcholine Versus Rocuronium-induced Neuromuscular Blockade

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Optimal dose of neuromuscular blocking agent during ECT [ Time Frame: Up to six weeks following inclusion ] [ Designated as safety issue: Yes ]
    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.

  • Compound specific differences in time to recovery from neuromuscular blockade [ Time Frame: Up to six weeks following inclusion ] [ Designated as safety issue: Yes ]
    The investigators would like to define 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.


Secondary Outcome Measures:
  • Differences in seizure duration between compounds [ Time Frame: Up to six weeks following inclusion ] [ Designated as safety issue: Yes ]
    Observational reports suggest that differences in seizure duration might exist depending on the neuromuscular blocking agents used to accomplish muscle strength control during ECT.


Estimated Enrollment: 30
Study Start Date: May 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMBA: Sux-Roc
Cross-over randomized controlled, assessor blinded clinical trial.
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 Name: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01441960

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Matthias Eikermann, MD, PhD Massachusetts General Hospital
Principal Investigator: Ala Nozari, MD, PhD Mass General Hospital
  More Information

Publications:
Responsible Party: Ala Nozari, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01441960     History of Changes
Other Study ID Numbers: 2010P001154
Study First Received: September 20, 2011
Last Updated: July 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Succinylcholine
Rocuronium
ECT

Additional relevant MeSH terms:
Rocuronium
Succinylcholine
Neuromuscular Agents
Neuromuscular Blocking Agents
Neuromuscular Depolarizing Agents
Neuromuscular Nondepolarizing Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014