Comparison of Thiopental and Propofol as Anaesteticum During ECT

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Depression	Drug: Propofol Thiopental	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Comparison of Thiopental and Propofol as Anaesteticum During ECT
Study Start Date :	January 2003
Estimated Study Completion Date :	December 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Number of ECT-treatments required to treat depression
2. Duration of seizures
3. Amount of energy required to initiate seizure

Secondary Outcome Measures :

1. EEG-related parameters
2. Changes in seizure-threshold
3. Haemodynamic parameters
4. Cognitive impairment

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Major depression, hospitalized

Exclusion Criteria:

• age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases

Contacts and Locations

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Locations

Denmark
Rigshospitalet, Department of Psychiatry	Recruiting
Blegdamsvej 9, Copenhagen, Denmark, 2100
Contact: Jeanett Ø Bauer, MD, pHD 0045 35819411 jeanett.bauer@mail.dk
Contact: Martin B Joergensen, M.D., pHD 0045 3545 6263 martinbj@rh.dk
Principal Investigator: Jeanett Ø Bauer, M.D., pHD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:	Martin Balslev Jørgensen, M.D	Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark

More Information

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ClinicalTrials.gov Identifier:	NCT00379886 History of Changes
Other Study ID Numbers:	ECT-Jan2004-Jan2007
First Posted:	September 25, 2006
Last Update Posted:	November 14, 2007
Last Verified:	November 2007

Keywords provided by Rigshospitalet, Denmark:

ECT; Depression; Anesthiticum; Propofol; Thiopental

Additional relevant MeSH terms:

Depression; Behavioral Symptoms; Propofol; Thiopental; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous	Anesthetics, General; Anesthetics; Anticonvulsants; GABA Modulators; GABA Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action