Comparison of Thiopental and Propofol as Anaesteticum During ECT

Condition(s) targeted: Depression

Intervention: Propofol Thiopental (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Rigshospitalet, Denmark

Official(s) and/or principal investigator(s):
Martin Balslev Jørgensen, M.D, Principal Investigator, Affiliation: Rigshospitalet, Department of Psychiatry, Copenhagen, 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.

Official title: Comparison of Thiopental and Propofol as Anaesteticum During ECT

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

Primary outcome:

Number of ECT-treatments required to treat depression

Duration of seizures

Amount of energy required to initiate seizure

Secondary outcome:

EEG-related parameters

Changes in seizure-threshold

Haemodynamic parameters

Cognitive impairment

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Major depression, hospitalized

Exclusion Criteria:

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

diseases

Rigshospitalet, Department of Psychiatry, Blegdamsvej 9, Copenhagen 2100, Denmark; Recruiting
Jeanett Ø Bauer, MD, pHD, Phone: 0045 35819411, Email: jeanett.bauer@mail.dk
Martin B Joergensen, M.D., pHD, Phone: 0045 3545 6263, Email: martinbj@rh.dk
Jeanett Ø Bauer, M.D., pHD, Principal Investigator

Starting date: January 2003
Last updated: November 13, 2007