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Three Anaesthesic Method in Electroconvulsive Theraphy

I

Inonu University

Status and phase

Completed
Phase 4

Conditions

Anesthesia

Treatments

Drug: Sevoflurane
Drug: Propofol
Drug: Remifentanil and propofol

Study type

Interventional

Funder types

Other

Identifiers

NCT01759589
Inonu University
Inonu University Anesthesia

Details and patient eligibility

About

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

Full 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.

Enrollment

39 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

39 participants in 3 patient groups, including a placebo group

propofol (Group P)
Placebo Comparator group
Description:
The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction
Treatment:
Drug: Propofol
remifentanil and propofol (Group R)
Active Comparator group
Description:
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
Treatment:
Drug: Remifentanil and propofol
sevoflurane (Group S)
Active Comparator group
Description:
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.
Treatment:
Drug: Sevoflurane

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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