Comparison of Thiopental and Propofol as Anaesteticum During ECT

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00379886
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 59
• Patients Per Site Per Month: 1.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression	Drug: Propofol Thiopental	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Comparison of Thiopental and Propofol as Anaesteticum During ECT
• Study Start Date: Jan 1, 2003
• Anticipated Study Completion Date: Dec 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of ECT-treatments required to treat depression []

2. Duration of seizures []

3. Amount of energy required to initiate seizure []

Secondary Outcome Measures

1. EEG-related parameters []

2. Changes in seizure-threshold []

3. Haemodynamic parameters []

4. Cognitive impairment []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Major depression, hospitalized

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet, Department of Psychiatry	Blegdamsvej 9	Copenhagen	Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00379886
• Other Study ID Numbers: ECT-Jan2004-Jan2007
• First Posted: Sep 25, 2006
• Last Update Posted: Nov 14, 2007
• Last Verified: Nov 1, 2007

• Keywords provided by , ,: ECT; Depression; Anesthiticum; Propofol; Thiopental
• Additional relevant MeSH terms: Depression; Thiopental; Propofol

Study Results

No Results Posted as of Nov 14, 2007