Text Size

Comparison of Thiopental and Propofol as Anaesteticum During ECT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00379886
First received: September 21, 2006
Last updated: November 13, 2007
Last verified: November 2007
History of Changes

September 21, 2006
November 13, 2007
January 2003
Not Provided
  • Number of ECT-treatments required to treat depression
  • Duration of seizures
  • Amount of energy required to initiate seizure
Same as current
Complete list of historical versions of study NCT00379886 on ClinicalTrials.gov Archive Site
  • EEG-related parameters
  • Changes in seizure-threshold
  • Haemodynamic parameters
  • Cognitive impairment
Same as current
Not Provided
Not Provided
 
Comparison of Thiopental and Propofol as Anaesteticum During ECT
Comparison of Thiopental and Propofol as Anaesteticum During ECT

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Depression
Drug: Propofol Thiopental
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2007
Not Provided

Inclusion Criteria:

  • Major depression, hospitalized

Exclusion Criteria:

  • age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
Both
18 Years and older
No
Not Provided
Denmark
 
NCT00379886
ECT-Jan2004-Jan2007
Not Provided
Not Provided
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Martin Balslev Jørgensen, M.D Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark
Rigshospitalet, Denmark
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP