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Three Anaesthesic Method in Electroconvulsive Theraphy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zekine Begec, Inonu University
ClinicalTrials.gov Identifier:
NCT01759589
First received: December 14, 2012
Last updated: December 31, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Anesthesia
 Drug: Propofol
Drug: Remifentanil and propofol
Drug: Sevoflurane
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Inonu University:

Primary Outcome Measures:
  • Seizure duration [ Time Frame: The patients were observed about seizure up to ten minutes after electrical stimulation ] [ Designated as safety issue: Yes ]
    After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.


Secondary Outcome Measures:
  • postictal suppression index [ Time Frame: completing seizure in one hour ] [ Designated as safety issue: Yes ]
    After anesthesia induction, patients were administered electrical stimulation. Then, postictal suppression index, a parameter that shows seizure quality, was determined from seizure records.

  • Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands) [ Time Frame: after seizure in one hour in operation room. ] [ Designated as safety issue: Yes ]
    The time from the end of succinylcholine administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.

  • 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. ] [ Designated as safety issue: Yes ]

    During perioperative period:

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



Enrollment: 39
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Volatil anesthetic

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759589

Locations
Turkey
Turgut Ozal Medical Center
Malatya, Turkey, 44315
Sponsors and Collaborators
Inonu University
Investigators
Study Director: Zekine Begec
  More Information

Publications:

Responsible Party: Zekine Begec, Principal Investigator, Inonu University
ClinicalTrials.gov Identifier: NCT01759589     History of Changes
Other Study ID Numbers: Inonu University Anesthesia, Inonu University
Study First Received: December 14, 2012
Last Updated: December 31, 2012
Health Authority: Turkey: Ethics Committee

Keywords provided by Inonu University:
electroconvulsive therapy,sevoflurane,propofol,remifentanil

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Remifentanil
Anesthetics, Intravenous
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
 Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013