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Comparison of Thiopental and Propofol as Anaesteticum During ECT

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ClinicalTrials.gov Identifier: NCT00379886
Recruitment Status : Unknown
Verified November 2007 by Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
First Posted : September 25, 2006
Last Update Posted : November 14, 2007
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Depression Drug: Propofol Thiopental Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Thiopental and Propofol as Anaesteticum During ECT
Study Start Date : January 2003
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Number of ECT-treatments required to treat depression
  2. Duration of seizures
  3. Amount of energy required to initiate seizure

Secondary Outcome Measures :
  1. EEG-related parameters
  2. Changes in seizure-threshold
  3. Haemodynamic parameters
  4. Cognitive impairment

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00379886


Locations
Denmark
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
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ClinicalTrials.gov Identifier: NCT00379886     History of Changes
Other Study ID Numbers: ECT-Jan2004-Jan2007
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: November 14, 2007
Last Verified: November 2007

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

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Propofol
Thiopental
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action