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

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ClinicalTrials.gov Identifier: NCT02819375
Recruitment Status : Completed
First Posted : June 30, 2016
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Ülkü Özgül, Inonu University

Tracking Information
First Submitted Date  ICMJE June 28, 2016
First Posted Date  ICMJE June 30, 2016
Last Update Posted Date February 27, 2019
Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
seizure activity [ Time Frame: intraoperative ]
Motor (EMG) and electroencephalogram (EEG) seizure durations
Original Primary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
seizure activity [ Time Frame: intraoperative ]
Motor (EMG) and electroencephalogram (EEG) seizure durations will recorded during the electroconvulsive therapy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2019)
  • 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
  • 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
  • recovery times [ Time Frame: intraoperative ]
    Recovery times will be assessed with spontaneous breathing, eye opening, obeying
Original Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2016)
  • 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 ]
  • 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 ]
  • recovery times [ Time Frame: intraoperative ]
    Recovery times will be assessed with spontaneous breathing, eye opening, obeying
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Propofol, Propofol-remifentanil and Propofol-ketamine Anesthesia During Electroconvulsive Therapy
Official Title  ICMJE Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
Brief Summary

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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anesthesia
  • Electroconvulsive Therapy
Intervention  ICMJE
  • Drug: Propofol
    1 mg/kg propofol
    Other Name: Diprivan
  • Drug: Propofol+Remifentanil
    0.5 mg/kg propofol+0.5 mg/kg remifentanil
    Other Name: Propofol+Ultiva
  • Drug: Propofol+Ketamine
    0.5 mg/kg propofol and 0.5 mg/kg ketamine
    Other Name: Propofol+Ketalar
Study Arms  ICMJE
  • Active Comparator: Group Propofol
    anesthesia will induced 1 mg/kg propofol
    Intervention: Drug: Propofol
  • Active Comparator: Group propofol/remifentanil
    anesthesia will induced 0.5 mg/kg propofol and 1 µg/kg remifentanil
    Intervention: Drug: Propofol+Remifentanil
  • Active Comparator: Group propofol/ketamine
    anesthesia will induced propofol 0.5 mg/kg and ketamine 0.5 mg/kg
    Intervention: Drug: Propofol+Ketamine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2016)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02819375
Other Study ID Numbers  ICMJE Ulku 2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ülkü Özgül, Inonu University
Study Sponsor  ICMJE Inonu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ulku Ozgul, Ass.Prof. Inonu University Faculty of Medicine
PRS Account Inonu University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP