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Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression

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ClinicalTrials.gov Identifier: NCT02924090
Recruitment Status : Unknown
Verified September 2016 by University of Manitoba.
Recruitment status was:  Recruiting
First Posted : October 5, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE September 30, 2016
First Posted Date  ICMJE October 5, 2016
Last Update Posted Date October 21, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • EEG seizure duration (seconds) [ Time Frame: Up to 3 minutes post ECT ]
    Duration of seizure spike wave morphology will be assessed by the attending psychiatrist and independently by a second psychiatrist.
  • ECT-induced seizure duration (seconds) [ Time Frame: Up to 3 minutes post ECT ]
    Duration of motor seizures will be assessed by timing the onset and offset of appropriate motor twitches in the intrinsic foot muscles and extra-ocular muscles by the attending psychiatrist.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 3, 2016)
  • Changes in cerebral metabolism assessed by cerebral saturation (%) [ Time Frame: Up to 5 minutes post ECT ]
    Cerebral metabolism will be assessed by continuous cerebral oximetry measurements using the ForeSight Cerebral Oximeter, from immediately prior to ECT to 5 minutes post ECT
  • Remission of depressive symptoms assessed by HAM-D [ Time Frame: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT ]
    Patients will be assessed using a clinician-administered Hamilton Depression Rating Scale (HAM-D) both prior to, and at intervals of 2, 4 and 8 weeks after completion of the study. The HAM-D is a validated healthcare professional-administered assessments of clinical depressive symptoms including: hopelessness, guilt or depressed mood and physical symptoms such as agitation, restlessness and fatigue.
  • Remission of depressive symptoms assessed by MADRS [ Time Frame: Approximately one week prior to, and at 2, 4 and 8 weeks post ECT ]
    Patients will be assessed using a clinician-administered Montgomery-Asberg Depression Scale (MADRS) both prior to, and at intervals of 2, 4 and 8 weeks after completion of the study. The MADRS is a validated healthcare professional-administered assessments of clinical depressive symptoms including: hopelessness, guilt or depressed mood and physical symptoms such as agitation, restlessness and fatigue.
  • Effect on blood pressure [ Time Frame: Up to 7 minutes post ECT ]
    Systolic, diastolic and mean blood pressure will be recorded every minute from immediately prior to 7 minutes post ECT.
  • Effect on heart rate [ Time Frame: Up to 7 minutes post ECT ]
    Heart rate (bpm) will be continuously recorded from immediately prior to 7 minutes post ECT.
  • Duration of stay in post-anesthesia care unit (hours) [ Time Frame: Up to 2 hours post arrival in post-anesthesia care unit (PACU). ]
  • Incidence of nausea in post-anesthesia care unit (%) [ Time Frame: Up to 2 hours post arrival in PACU. ]
    The number of instances of nausea while in PACU will be recorded.
  • Incidence of vomiting in post-anesthesia care unit (%) [ Time Frame: Up to 2 hours post arrival in PACU. ]
    The number of instances of vomiting while in PACU will be recorded.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hyperventilation Combined With Etomidate or Ketamine Anesthesia in ECT Treatment of Major Depression
Official Title  ICMJE Hyperventilation and ECT Seizure Duration: Effects on Cerebral Oxygen Saturation, and Therapeutic Outcome With Comparisons Between Etomidate and Ketamine in Patients With Major Depressive Disorder
Brief Summary This is a randomized controlled study assessing the effect of pre-emptive hyperventilation on ECT seizure duration, cerebral desaturation and remission of depressive symptoms in patients with Major Depressive Disorder. Comparison of etomidate and ketamine on remission of depressive symptoms with and without pre-emptive hyperventilation will also be studied.
Detailed Description

Electroconvulsive therapy (ECT) is an effective treatment for medication-resistant forms of depression, including major depressive disorder and mania. Therapeutic success of ECT is related to the duration and quality of Electroencephalogram (EEG) and motor seizures. Previous studies have demonstrated that deliberate hyperventilation augments seizure duration in anesthetized subjects. It has also been shown that seizure activity significantly increases cerebral metabolic rate, predisposing the patient to potentially severe cerebral desaturation events. These desaturation events are predicted to be exacerbated by pre-emptive hyperventilation which has a potent cerebral vasoconstrictive effect. Despite the widespread use of ECT, little is known about the effect of hyperventilation on cerebral metabolism in this setting. Ketamine has recently been demonstrated to have anti-depressant properties in patients with major depressive disorder, suggesting that patients treated with ketamine anesthesia and then ECT, may benefit clinically from the additive effects of both treatment modalities, compared to ECT alone.

The investigators hypothesize that hyperventilation will facilitate prolonged seizure duration and faster remission of depressive symptoms. As well there may be significant cerebral desaturation and cardiovascular side effects of ECT therapy following hyperventilation. Lastly, the effect of hyperventilation on the efficacy of ECT therapy may be improved when ketamine anesthesia is used simultaneously. To test this hypothesis this study will compare ketamine anesthesia to etomidate anesthesia. Etomidate is a short acting anesthetic that is commonly used in these procedures.

The study objectives (primary and secondary) are as follows:

  1. To quantify the effect of hyperventilation and type of anesthetic agent on ECT-induced seizure duration
  2. To assess the effect of hyperventilation immediately prior to ECT on cerebral metabolism as measured by cerebral oximetry
  3. To determine the effect of hyperventilation and anesthetic agent on the remission of symptoms in Major Depressive Disorder
  4. To assess the side effect profile of hyperventilation during ECT on hemodynamics
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Etomidate
    Etomidate will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.3 mg/kg
    Other Name: Amidate
  • Drug: Ketamine
    Ketamine will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.5 to 1.0 mg/kg.
    Other Name: Ketalar
  • Procedure: Hyperventilation
    Hyperventilation will be performed in patients after full pre-oxygenation and induction of anesthesia, by administering 20 breaths in 30 seconds using a well-fitting face mask immediately before application of the ECT electrical stimulus.
  • Procedure: Electroconvulsive therapy (ECT)
    Bilateral, bitemporal electrode placement will be utilized to elicit a seizure via a SpECTrun 5000Q (MECTA Inc.). The electrical dose required will be determined in advance by the patient's attending psychiatrist.
Study Arms  ICMJE
  • Active Comparator: ECT with Etomidate
    Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose.
    Interventions:
    • Drug: Etomidate
    • Procedure: Electroconvulsive therapy (ECT)
  • Active Comparator: ECT with Ketamine
    Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose.
    Interventions:
    • Drug: Ketamine
    • Procedure: Electroconvulsive therapy (ECT)
  • Active Comparator: ECT with Etomidate and Hyperventilation
    Immediately prior to ECT study patients will be administered intravenous etomidate for anesthesia at a dose of 0.3 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
    Interventions:
    • Drug: Etomidate
    • Procedure: Hyperventilation
    • Procedure: Electroconvulsive therapy (ECT)
  • Active Comparator: ECT with Ketamine and Hyperventilation
    Immediately prior to ECT study patients will be administered intravenous ketamine for anesthesia at a dose of 0.5 -1.0 mg/kg given as a bolus dose. Hyperventilation will be administered (20 breaths in 30 seconds) by face mask immediately prior to ECT.
    Interventions:
    • Drug: Ketamine
    • Procedure: Hyperventilation
    • Procedure: Electroconvulsive therapy (ECT)
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 3, 2016)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults patients aged 18 to 85 years
  • Diagnosed with Major Depressive Disorder, unipolar or bipolar depression
  • Undergoing ECT for treatment of their symptoms
  • Currently residing in Manitoba

Exclusion Criteria:

  • Relative contraindications to ECT therapy (recent MI or CVA, increased intracranial pressure, intracranial mass lesion, intracranial aneurysm, epilepsy, known cardiac arrhythmia, pheochromocytoma, pregnancy)
  • Contraindications to etomidate (sepsis, primary or secondary adrenal insufficiency, porphyria)
  • DSM-V diagnosis of a lifetime history of psychotic spectrum disorder
  • Drug or alcohol dependence, or abuse within the past 3 months, soy-bean oil allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02924090
Other Study ID Numbers  ICMJE B2015050
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Manitoba
Study Sponsor  ICMJE University of Manitoba
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ian McIntyre, MD, MSc University of Manitoba
Principal Investigator: Michael Harrington, MD University of Manitoba
PRS Account University of Manitoba
Verification Date September 2016

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