Comparison of Thiopental and Propofol as Anaesteticum During ECT

November 13, 2007 updated by: Rigshospitalet, Denmark

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Copenhagen
      • Blegdamsvej 9, Copenhagen, Denmark, 2100
        • Recruiting
        • Rigshospitalet, Department of Psychiatry
        • Contact:
        • Contact:
          • Martin B Joergensen, M.D., pHD
          • Phone Number: 0045 3545 6263
          • Email: martinbj@rh.dk
        • Principal Investigator:
          • Jeanett Ø Bauer, M.D., pHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Major depression, hospitalized

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Haemodynamic parameters
EEG-related parameters
Changes in seizure-threshold
Cognitive impairment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion (ANTICIPATED)

December 1, 2007

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 21, 2006

First Posted (ESTIMATE)

September 25, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

November 14, 2007

Last Update Submitted That Met QC Criteria

November 13, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECT-Jan2004-Jan2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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