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Clinical Trials/NCT01759589
NCT01759589
Completed
Phase 4

Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

Inonu University1 site in 1 country39 target enrollmentJanuary 2011

Overview

Phase
Phase 4
Intervention
Propofol
Conditions
Anesthesia
Sponsor
Inonu University
Enrollment
39
Locations
1
Primary Endpoint
Seizure duration
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
January 2011
End Date
August 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zekine Begec

Principal Investigator

Inonu University

Eligibility 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
  • 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.

Arms & Interventions

propofol (Group P)

The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction

Intervention: Propofol

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

Intervention: Remifentanil and propofol

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.

Intervention: Sevoflurane

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • postictal suppression index(completing seizure in one hour)
  • Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)(after seizure in one hour in operation room.)
  • Hemodynamic variables(Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.)

Study Sites (1)

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