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Completed

NCT Number: NCT01759589

Three Anaesthesic Method in Electroconvulsive Theraphy

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

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Turgut Ozal Medical Center

Malatya, 44315, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

1 mg/kg propofol IV (over 15 sec) during anesthesia induction

Other names: Intravenous anesthetic agent

remifentanil and propofol

Drug

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

Sevoflurane

Drug

Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered

Other names: Volatil anesthetic

Primary outcomes

  1. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 3, 2013
Registry last updated
Jan 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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