Comparison of Thiopental and Propofol as Anaesteticum During ECT

NCT00379886 | Unknown

• 1 other identifier: ECT-Jan2004-Jan2007
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

ECT; Depression; Anesthiticum; Propofol; Thiopental

Outcome Measures

Primary Outcomes (3)

• Number of ECT-treatments required to treat depression

• Duration of seizures

• Amount of energy required to initiate seizure

Secondary Outcomes (4)

• EEG-related parameters

• Changes in seizure-threshold

• Haemodynamic parameters

• Cognitive impairment

Interventions

Propofol Thiopental DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major depression, hospitalized

You may not qualify if:

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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet, Department of Psychiatry

Blegdamsvej 9, Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Martin Balslev Jørgensen, M.D

  Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 21, 2006
• First Posted: September 25, 2006
• Study Start: January 1, 2003
• Study Completion: December 1, 2007
• Last Updated: November 14, 2007

Record last verified: 2007-11

Locations

DK (1)