Comparison of Thiopental and Propofol as Anaesteticum During ECT

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Rigshospitalet, Denmark.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00379886
First received: September 21, 2006
Last updated: November 13, 2007
Last verified: November 2007
  Purpose

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 Intervention
Depression
Drug: Propofol Thiopental

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Thiopental and Propofol as Anaesteticum During ECT

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

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

Estimated Enrollment: 100
Study Start Date: January 2003
Estimated Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depression, hospitalized

Exclusion Criteria:

  • age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379886

Locations
Denmark
Rigshospitalet, Department of Psychiatry Recruiting
Blegdamsvej 9, Copenhagen, Denmark, 2100
Contact: Jeanett Ø Bauer, MD, pHD    0045 35819411    jeanett.bauer@mail.dk   
Contact: Martin B Joergensen, M.D., pHD    0045 3545 6263    martinbj@rh.dk   
Principal Investigator: Jeanett Ø Bauer, M.D., pHD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Martin Balslev Jørgensen, M.D Rigshospitalet, Department of Psychiatry, Copenhagen, Denmark
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00379886     History of Changes
Other Study ID Numbers: ECT-Jan2004-Jan2007
Study First Received: September 21, 2006
Last Updated: November 13, 2007
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Rigshospitalet, Denmark:
ECT
Depression
Anesthiticum
Propofol
Thiopental

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Propofol
Thiopental
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticonvulsants
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014