Comparison of Thiopental and Propofol as Anaesteticum During ECT

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2007-12-31

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.

Detailed Description

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Conditions

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Depression

Keywords

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ECT Depression Anesthiticum Propofol Thiopental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Propofol Thiopental

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Martin Balslev Jørgensen, M.D

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark

Locations

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Rigshospitalet, Department of Psychiatry

Blegdamsvej 9, Copenhagen, Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Jeanett Ø Bauer, MD, pHD

Role: primary

Martin B Joergensen, M.D., pHD

Role: backup

Other Identifiers

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ECT-Jan2004-Jan2007

Identifier Type: -

Identifier Source: org_study_id