Recruiting

Hyperventilation & Etomidate

Sponsor:

University of Manitoba

Code:

NCT02924090

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Etomidate

Ketamine

Hyperventilation

Electroconvulsive therapy (ECT)

Study Details

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.

Conditions

Depression

Study ID

NCT02924090

Start date

Sep, 2016

Status verified date

Sep, 2016

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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

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

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.

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.

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.

Primary outcome measure

  • EEG seizure duration (seconds) [ Time Frame: Up to 3 minutes post ECT ]
  • ECT-induced seizure duration (seconds) [ Time Frame: Up to 3 minutes post ECT ]

Central Contacts and Locations

Central contacts

Ian McIntyre, MD, MSc

204 787-1414ian.mcintyre@umanitoba.ca

Locations

Health Sciences Centre

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Contacts

Ian McIntyre, MD, MSc

204 787-2560ian.mcintyre@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Oct 21, 2016

Last verified

Sep, 2016

Keywords

  • Major depressive disorder
  • Etomidate
  • Ketamine
  • Hyperventilation
  • Electroconvulsive therapy
  • Depression
  • Anesthesia
  • Nervous System Diseases
  • Mental Disorders
  • Electroencephalography
  • Cerebral Metabolism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2016-10-21.