Comparison of Thiopental and Propofol as Anaesteticum During ECT

Depression Clinical Trial

Official title:

Comparison of Thiopental and Propofol as Anaesteticum During ECT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00379886
• Other study ID #: ECT-Jan2004-Jan2007
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2006
• Last updated: November 13, 2007
• Start date: January 2003
• Est. completion date: December 2007

Study information

• Verified date: November 2007
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major depression, hospitalized

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Drug:
• Propofol Thiopental

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Department of Psychiatry	Blegdamsvej 9	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ECT-treatments required to treat depression
Primary	Duration of seizures
Primary	Amount of energy required to initiate seizure
Secondary	EEG-related parameters
Secondary	Changes in seizure-threshold
Secondary	Haemodynamic parameters
Secondary	Cognitive impairment