Effect of the Addition of Ketamine to Sevoflurane Anesthesia in Electroconvulsive Therapy

Ketamine

Brief Summary

The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.

Intervention / Treatment

  • Sevoflurane (DRUG)
    Inhalation anesthetic agent
  • Ketamine (DRUG)
    Intravenous anesthetic agent
  • Saline (DRUG)
    Isotonic solution for placebo group

Condition or Disease

  • Depressive Disorder

Phase

  • Phase 4

    • Study Design

    Study type: INTERVENTIONAL
    Status: Unknown status
    Study results: No Results Available
    Age: 18 Years to 70 Years
    Enrollment: 60 (ESTIMATED)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    DOUBLE:
    • Participant
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2014
    Primary Completion: Oct 01, 2014 ESTIMATED
    Completion Date: Oct 01, 2014 ESTIMATED
    Study First Posted: Oct 20, 2014 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Oct 15, 2014

    Sponsors / Collaborators

    Lead Sponsor: Inonu University
    Responsible Party: N/A

    Location

    Malatya, Turkey

    Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.

    Participant Groups

    • Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner.

    • Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner.

    Eligibility Criteria

    Sex: All
    Minimum Age: 18
    Maximum Age: 70
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Major depressive patients

    Exclusion Criteria:

    * Pregnancy
    * Have a history of myocardial infarction in the previous six months
    * Atrial fibrillation or flutter
    * Heart block
    * Unregulated hypertension
    * Cerebrovascular diseases
    * A known drug allergy

    Primary Outcomes

    • the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.

    Secondary Outcomes

    • Mean arterial pressure (MAP) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).

    • Heart rate (HR) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively).

    More Details

    NCT Number: NCT02267980
    Other IDs: Inonu 2
    Study URL: https://clinicaltrials.gov/study/NCT02267980
    Last updated: Sep 29, 2023