Comparison of Thiopental and Propofol as Anaesteticum During ECT
Recruitment status was: Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Thiopental and Propofol as Anaesteticum During ECT|
- Number of ECT-treatments required to treat depression
- Duration of seizures
- Amount of energy required to initiate seizure
- EEG-related parameters
- Changes in seizure-threshold
- Haemodynamic parameters
- Cognitive impairment
|Study Start Date:||January 2003|
|Estimated Study Completion Date:||December 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00379886
|Rigshospitalet, Department of Psychiatry|
|Blegdamsvej 9, Copenhagen, Denmark, 2100|
|Principal Investigator:||Martin Balslev Jørgensen, M.D||Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark|