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Comparison of Thiopental and Propofol as Anaesteticum During ECT
This study is currently recruiting participants.
Verified by Rigshospitalet, Denmark, November 2007
First Received: September 21, 2006   Last Updated: November 13, 2007   History of Changes
Sponsor: Rigshospitalet, Denmark
Information provided by: Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT00379886
  Purpose

Electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. General anesthesia is used during the treatment. Since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used.

Methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric departments.

Several studies have shown that Propofol reduce seizure duration in comparison with barbiturates. So far, no studies have demonstrated any clinical implications of the reduced seiziure duration. However, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ECT was used.

The aim of this study is to compare the clinical effect of ECT in patients anesthesized with either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found with Propofol as anestheticum will increase the number of treatments needed to clinial respons. Furthermore we want to study differences in EEG-relate parameters previously shown to have prognostic value. Hospitalized patients with major depression, who is to be treated with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated with Hamilton depression scale and BDI before treatment, after six treatments and when treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE to evaluate their degree of cognitive impairment.


Condition Intervention
Depression
Drug: Propofol Thiopental

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Comparison of Thiopental and Propofol as Anaesteticum During ECT

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Number of ECT-treatments required to treat depression
  • Duration of seizures
  • Amount of energy required to initiate seizure

Secondary Outcome Measures:
  • EEG-related parameters
  • Changes in seizure-threshold
  • Haemodynamic parameters
  • Cognitive impairment

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depression, hospitalized

Exclusion Criteria:

  • age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379886

Locations
Denmark, Copenhagen
Rigshospitalet, Department of Psychiatry Recruiting
Blegdamsvej 9, Copenhagen, Denmark, 2100
Contact: Jeanett Ø Bauer, MD, pHD     0045 35819411     jeanett.bauer@mail.dk    
Contact: Martin B Joergensen, M.D., pHD     0045 3545 6263     martinbj@rh.dk    
Principal Investigator: Jeanett Ø Bauer, M.D., pHD            
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Martin Balslev Jørgensen, M.D Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark
  More Information

No publications provided

Study ID Numbers: ECT-Jan2004-Jan2007
Study First Received: September 21, 2006
Last Updated: November 13, 2007
ClinicalTrials.gov Identifier: NCT00379886     History of Changes
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
ECT
Depression
Anesthiticum
Propofol
Thiopental

Additional relevant MeSH terms:
Anesthetics, Intravenous
Neurotransmitter Agents
Depression
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Thiopental
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Mental Disorders
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
Mood Disorders
GABA Agents
Propofol
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010