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

NCT02924090 | Unknown Phase 4

• 1 other identifier: B2015050
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• EEG seizure duration (seconds)

  Duration of seizure spike wave morphology will be assessed by the attending psychiatrist and independently by a second psychiatrist.

  Up to 3 minutes post ECT

• ECT-induced seizure duration (seconds)

  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.

  Up to 3 minutes post ECT

Secondary Outcomes (8)

• Changes in cerebral metabolism assessed by cerebral saturation (%)

  Up to 5 minutes post ECT

• Remission of depressive symptoms assessed by HAM-D

  Approximately one week prior to, and at 2, 4 and 8 weeks post ECT

• Remission of depressive symptoms assessed by MADRS

  Approximately one week prior to, and at 2, 4 and 8 weeks post ECT

• Effect on blood pressure

  Up to 7 minutes post ECT

• Effect on heart rate

  Up to 7 minutes post ECT

Study Arms (4)

ECT with Etomidate

ACTIVE COMPARATOR

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.

Drug: Etomidate; Procedure: Electroconvulsive therapy (ECT)

ECT with Ketamine

ACTIVE COMPARATOR

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.

Drug: Ketamine; Procedure: Electroconvulsive therapy (ECT)

ECT with Etomidate and Hyperventilation

ACTIVE COMPARATOR

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.

Drug: Etomidate; Procedure: Hyperventilation; Procedure: Electroconvulsive therapy (ECT)

ECT with Ketamine and Hyperventilation

ACTIVE COMPARATOR

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.

Drug: Ketamine; Procedure: Hyperventilation; Procedure: Electroconvulsive therapy (ECT)

Interventions

Etomidate DRUG

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

Also known as: Amidate

ECT with Etomidate; ECT with Etomidate and Hyperventilation

Ketamine DRUG

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.

Also known as: Ketalar

ECT with Ketamine; ECT with Ketamine and Hyperventilation

Hyperventilation PROCEDURE

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.

ECT with Etomidate and Hyperventilation; ECT with Ketamine and Hyperventilation

Electroconvulsive therapy (ECT) PROCEDURE

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.

ECT with Etomidate; ECT with Etomidate and Hyperventilation; ECT with Ketamine; ECT with Ketamine and Hyperventilation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

RECRUITING

Related Publications (4)

• Loo C, Simpson B, MacPherson R. Augmentation strategies in electroconvulsive therapy. J ECT. 2010 Sep;26(3):202-7. doi: 10.1097/YCT.0b013e3181e48143.

  PMID: 20562640 BACKGROUND

• Aksay SS, Bumb JM, Janke C, Hoyer C, Kranaster L, Sartorius A. New evidence for seizure quality improvement by hyperoxia and mild hypocapnia. J ECT. 2014 Dec;30(4):287-91. doi: 10.1097/YCT.0000000000000109.

  PMID: 24625713 BACKGROUND

• Fabbri F, Henry ME, Renshaw PF, Nadgir S, Ehrenberg BL, Franceschini MA, Fantini S. Bilateral near-infrared monitoring of the cerebral concentration and oxygen-saturation of hemoglobin during right unilateral electro-convulsive therapy. Brain Res. 2003 Dec 5;992(2):193-204. doi: 10.1016/j.brainres.2003.08.034.

  PMID: 14625058 BACKGROUND

• Ghasemi M, Kazemi MH, Yoosefi A, Ghasemi A, Paragomi P, Amini H, Afzali MH. Rapid antidepressant effects of repeated doses of ketamine compared with electroconvulsive therapy in hospitalized patients with major depressive disorder. Psychiatry Res. 2014 Feb 28;215(2):355-61. doi: 10.1016/j.psychres.2013.12.008. Epub 2013 Dec 13.

  PMID: 24374115 BACKGROUND

MeSH Terms

Conditions

Depression; Depressive Disorder, Major; Hyperventilation; Nervous System Diseases; Mental Disorders

Interventions

Etomidate; Ketamine; Electroconvulsive Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Ian McIntyre, MD, MSc

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Michael Harrington, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ian McIntyre, MD, MSc

CONTACT

204 787-1414; ian.mcintyre@umanitoba.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 5, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: October 21, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)