Comparison of Thiopental and Propofol as Anaesteticum During ECT
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Thiopental and Propofol as Anaesteticum During ECT|
|Study Start Date :||January 2003|
|Estimated Study Completion Date :||December 2007|
- 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
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
|Rigshospitalet, Department of Psychiatry||Recruiting|
|Blegdamsvej 9, Copenhagen, Denmark, 2100|
|Contact: Jeanett Ø Bauer, MD, pHD 0045 35819411 email@example.com|
|Contact: Martin B Joergensen, M.D., pHD 0045 3545 6263 firstname.lastname@example.org|
|Principal Investigator: Jeanett Ø Bauer, M.D., pHD|
|Principal Investigator:||Martin Balslev Jørgensen, M.D||Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark|