Comparison of Thiopental and Propofol as Anaesteticum During ECT

Study Overview
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Brief Summary
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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.

Official Title
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Comparison of Thiopental and Propofol as Anaesteticum During ECT

Conditions
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Depression

Intervention / Treatment
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* Drug: Propofol Thiopental


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Major depression, hospitalized Exclusion Criteria: age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Propofol Thiopental|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ECT-treatments required to treat depression |  |  | 
| Duration of seizures |  |  | 
| Amount of energy required to initiate seizure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG-related parameters |  |  | 
| Changes in seizure-threshold |  |  | 
| Haemodynamic parameters |  |  | 
| Cognitive impairment |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ECT, Depression, Anesthiticum, Propofol, Thiopental