Comparison of Thiopental and Propofol as Anaesteticum During ECT
- Conditions
- Depression
- Registration Number
- NCT00379886
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Major depression, hospitalized
- age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Duration of seizures Number of ECT-treatments required to treat depression Amount of energy required to initiate seizure
- Secondary Outcome Measures
Name Time Method EEG-related parameters Changes in seizure-threshold Cognitive impairment Haemodynamic parameters
Trial Locations
- Locations (1)
Rigshospitalet, Department of Psychiatry
🇩🇰Blegdamsvej 9, Copenhagen, Denmark