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Comparison of Thiopental and Propofol as Anaesteticum During ECT

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Propofol Thiopental
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring ECT, Depression, Anesthiticum, Propofol, Thiopental

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Major depression, hospitalized

Exclusion Criteria:

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

Sites / Locations

  • Rigshospitalet, Department of PsychiatryRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 21, 2006
Last Updated
November 13, 2007
Sponsor
Rigshospitalet, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00379886
Brief Title
Comparison of Thiopental and Propofol as Anaesteticum During ECT
Official Title
Comparison of Thiopental and Propofol as Anaesteticum During ECT
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Unknown status
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Rigshospitalet, Denmark

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
ECT, Depression, Anesthiticum, Propofol, Thiopental

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Propofol Thiopental
Primary Outcome Measure Information:
Title
Number of ECT-treatments required to treat depression
Title
Duration of seizures
Title
Amount of energy required to initiate seizure
Secondary Outcome Measure Information:
Title
EEG-related parameters
Title
Changes in seizure-threshold
Title
Haemodynamic parameters
Title
Cognitive impairment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major depression, hospitalized Exclusion Criteria: age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Balslev Jørgensen, M.D
Organizational Affiliation
Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet, Department of Psychiatry
City
Blegdamsvej 9
State/Province
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeanett Ø Bauer, MD, pHD
Phone
0045 35819411
Email
jeanett.bauer@mail.dk
First Name & Middle Initial & Last Name & Degree
Martin B Joergensen, M.D., pHD
Phone
0045 3545 6263
Email
martinbj@rh.dk
First Name & Middle Initial & Last Name & Degree
Jeanett Ø Bauer, M.D., pHD

12. IPD Sharing Statement

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Comparison of Thiopental and Propofol as Anaesteticum During ECT

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