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NCT Number: NCT02819375

Comparison of Propofol, Propofol-remifentanil and Propofol-ketamine Anesthesia During Electroconvulsive Therapy

Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and other psychiatric diseases. Currently, most ECT procedures are carried out with muscle paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to establish an accurate balance between adequate anaesthesia depth and optimal seizure duration.

We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol with remifentanil and propofol with ketamine), with respect to seizure duration and seizure quality in patients undergoing electroconvulsive therapy.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

In this study, 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who were scheduled for ECT sessions under general anesthesia. Seven consecutive ECT sessions will evaluated in this study. Exclusion criteria; pregnancy, cerebrovascular disease, epilepsy, unstable cardiovascular disease, chronic obstructive pulmonary disease, and renal or hepatic failure.

Electrocardiogram (ECG), noninvasive arterial blood pressure, and peripheral oxygen saturation (SpO2) measurements will utilized along with standard monitoring techniques in the operating room for patients who did not receive pre-operative medication. A 20-gauge intravenous cannula will placed before induction of patients. Each patient will receive either propofol 1 mg/kg alone (Group P), propofol 0.5 mg/kg and remifentanil 1 µg/kg (Group R), or propofol 0.5 mg/kg and ketamine 0.5 mg/kg (Group K) for their all electroconvulsive therapy session. A pneumatic tourniquet will applied to the arm and then will inflated to isolate blood circulation and allow for an accurate assessment of the motor seizure. Rocuronium (0.3 mg/kg bolus) will administered intravenously and ventilation will assisted using a facemask and 100% oxygen in three groups. Electrostimulus will performed via bifrontotemporal electrodes with a Thymatron System IV ECT Instrument (Somatics Inc.; Lake Bluff, IL, USA) by a psychiatrist who was blind to the study groups. In the initial session, patients will received ECT with 30-50% of the maximum output stimulus, depending on the preference of the psychiatrist. Thereafter, the same psychiatrist will arranged the stimulus amplitudes according to the clinical results of each patient.

The duration of the EEG, motor seizure, and postictal suppression index (PSI) will recorded from the EEG and electromyography traces. Heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), and peripheral oxygen saturation (SpO2) values will taken before anesthesia induction (Tbaseline), after the induction (T0), and following the ECT session at 1 (T1), 3 (T3), and 10 (T10) minutes. Time from the end of rocuronium administration to the time of recovery of spontaneous breathing, time of eye opening, and time of obeying verbal commands will recorded. The presence of complications, such as arrhythmia, laryngospasm, and agitation, will also recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Study include 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who scheduled for ECT sessions under general anesthesia

Exclusion criteria

  • Pregnancy
  • Cerebrovascular disease
  • Epilepsy
  • Unstable cardiovascular disease
  • Chronic obstructive pulmonary disease
  • Renal or hepatic failure

Treatment and study plan

Propofol

Drug

1 mg/kg propofol

Other names: Diprivan

Propofol+Remifentanil

Drug

0.5 mg/kg propofol+0.5 mg/kg remifentanil

Other names: Propofol+Ultiva

Propofol+Ketamine

Drug

0.5 mg/kg propofol and 0.5 mg/kg ketamine

Other names: Propofol+Ketalar

Primary outcomes

  1. seizure activity

    Time frame: intraoperative

    Motor (EMG) and electroencephalogram (EEG) seizure durations

Secondary outcomes

  1. heart rate (HR)

    Time frame: (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes

    heart rate

  2. mean arterial pressure (MAP)

    Time frame: (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes

    mean arterial pressure

  3. recovery times

    Time frame: intraoperative

    Recovery times will be assessed with spontaneous breathing, eye opening, obeying

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2016
Registry last updated
Feb 27, 2019

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

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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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