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

NCT01441960 | Completed Results DMC

• 1 other identifier: 2010P001154
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuromuscular Blockade; ECT

Keywords

Succinylcholine; Rocuronium; ECT

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to six weeks following inclusion

Secondary Outcomes (2)

• Compound Specific Differences in Time to Recovery From Neuromuscular Blockade

  Up to six weeks following inclusion

• Differences in Seizure Duration Between Compounds

  Up to six weeks following inclusion

Study Arms (2)

Succinylcholine first, then Rocuronium

EXPERIMENTAL

Cross-over randomized controlled, assessor blinded clinical trial.

Drug: Succinylcholine; Drug: Rocuronium

Rocuronium first, then succinylcholine

EXPERIMENTAL

Cross-over randomized controlled, assessor blinded clinical trial.

Drug: Succinylcholine; Drug: Rocuronium

Interventions

Succinylcholine DRUG

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'.

Also known as: Suxamethonium

Rocuronium first, then succinylcholine; Succinylcholine first, then Rocuronium

Rocuronium DRUG

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.

Rocuronium first, then succinylcholine; Succinylcholine first, then Rocuronium

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (6)

• Cheam EW, Critchley LA, Chui PT, Yap JC, Ha VW. Low dose mivacurium is less effective than succinylcholine in electroconvulsive therapy. Can J Anaesth. 1999 Jan;46(1):49-51. doi: 10.1007/BF03012514.

  PMID: 10078403 BACKGROUND

• Turkkal DC, Gokmen N, Yildiz A, Iyilikci L, Gokel E, Sagduyu K, Gunerli A. A cross-over, post-electroconvulsive therapy comparison of clinical recovery from rocuronium versus succinylcholine. J Clin Anesth. 2008 Dec;20(8):589-93. doi: 10.1016/j.jclinane.2008.06.006.

  PMID: 19100931 BACKGROUND

• Wagner KJ, Mollenberg O, Rentrop M, Werner C, Kochs EF. Guide to anaesthetic selection for electroconvulsive therapy. CNS Drugs. 2005;19(9):745-58. doi: 10.2165/00023210-200519090-00002.

  PMID: 16142990 BACKGROUND

• Eikermann M, Hunkemoller I, Peine L, Armbruster W, Stegen B, Husing J, Peters J. Optimal rocuronium dose for intubation during inhalation induction with sevoflurane in children. Br J Anaesth. 2002 Aug;89(2):277-81. doi: 10.1093/bja/aef177.

  PMID: 12378667 BACKGROUND

• Miguel RV, Soto R, Dyches P. A double-blind, randomized comparison of low-dose rocuronium and atracurium in a desflurane anesthetic. J Clin Anesth. 2001 Aug;13(5):325-9. doi: 10.1016/s0952-8180(01)00282-3.

  PMID: 11498311 BACKGROUND

• Reynolds LM, Lau M, Brown R, Luks A, Fisher DM. Intramuscular rocuronium in infants and children. Dose-ranging and tracheal intubating conditions. Anesthesiology. 1996 Aug;85(2):231-9. doi: 10.1097/00000542-199608000-00002.

  PMID: 8712436 BACKGROUND

MeSH Terms

Interventions

Succinylcholine; Rocuronium

Intervention Hierarchy (Ancestors)

Choline; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Onium Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Ala Nozari
• Organization: Mass General Hospital

anozari@partners.org

978-318-3933

Study Officials

• Matthias Eikermann, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Ala Nozari, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2011
• First Posted: September 28, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: February 1, 2015
• Last Updated: June 2, 2015
• Results First Posted: June 2, 2015

Record last verified: 2015-06

Locations

US (1)