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

Ketamine

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.

Intervention / Treatment

  • Drug: Etomidate
  • Drug: Ketamine
  • Procedure: Hyperventilation
  • Procedure: electroconvulsive therapy (ECT)

Condition or Disease

  • Depression

Phase

Study Design

Study type: Interventional
Status: Unknown status
Study results: No Results Available
Age: 18 Years to 85 Years   (Adult, Older Adult)
Enrollment: 48 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Sep 16, 2020
Primary Completion: Dec 17, 2020
Completion Date: Dec 18, 2020
Study First Posted: Oct 05, 2016
Results First Posted: Aug 31, 2020
Last Updated: Oct 21, 2016

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Winnipeg, Manitoba, Canada

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

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 85

More Details

NCT Number: NCT02924090
Other IDs: B2015050
Study URL: https://ClinicalTrials.gov/show/NCT02924090
Last updated: Jun 17, 2022