Three Anaesthesic Method in Electroconvulsive Theraphy

December 31, 2012 updated by: Zekine Begec, Inonu University

Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Malatya, Turkey, 44315
        • Turgut Ozal Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,
  • Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)

Exclusion Criteria:

  • Involuntary patient status
  • Patients with known or self-declared needle or mask phobia
  • Pregnancy
  • Asthma
  • Cerebrovascular disease,
  • History of myocardial infarction in the previous 6 months,
  • Atrial fibrillation or flutter,heart block,
  • A known or family history of reactions to the study drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: propofol (Group P)
The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction
Drug: Propofol
1 mg/kg propofol IV (over 15 sec) during anesthesia induction
Other Names:
  • Intravenous anesthetic agent
Active Comparator: remifentanil and propofol (Group R)
Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
Drug: Remifentanil and propofol
1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
Other Names:
  • Opioid and intravenous anesthetic agent
Active Comparator: sevoflurane (Group S)
In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped.
Drug: Sevoflurane
Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered
Other Names:
  • Volatil anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure duration
Time Frame: The patients were observed about seizure up to ten minutes after electrical stimulation
After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.
The patients were observed about seizure up to ten minutes after electrical stimulation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postictal suppression index
Time Frame: completing seizure in one hour
After anesthesia induction, patients were administered electrical stimulation. Then, postictal suppression index, a parameter that shows seizure quality, was determined from seizure records.
completing seizure in one hour
Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)
Time Frame: after seizure in one hour in operation room.
The time from the end of succinylcholine administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.
after seizure in one hour in operation room.
Hemodynamic variables
Time Frame: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.

During perioperative period:

Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.
Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Investigators

  • Study Director: Zekine Begec

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 31, 2012

First Posted (Estimate)

January 3, 2013

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

December 31, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Inonu University Anesthesia
  • Inonu University (Inonu University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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