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

Depressive Disorder Clinical Trial

Official title:

Turgut Ozal Medical Center Department of Anesthesiology and Reanimation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02267980
• Other study ID #: Inonu 2
• Status: Recruiting
• Phase: Phase 4
• First received: October 9, 2014
• Last updated: October 15, 2014
• Start date: July 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Inonu University
• Contact: Feray Erdil, MD
• Phone: 904223410660
• Email: feray.erdil[@]inonu.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Drug:
• Sevoflurane
Inhalation anesthetic agent
• Ketamine
Intravenous anesthetic agent
• Saline
Isotonic solution for placebo group

Locations

Country	Name	City	State
Turkey	Turgut Ozal Medical Center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgiç T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seizure duration	the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm.	During electroconvulsive therapy (30 minutes)	Yes
Secondary	Mean arterial pressure (MAP)	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).	During Electroconvulsive therapy (30 minutes)	Yes
Secondary	Heart rate (HR)	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).	During Electroconvulsive therapy (30 minutes)	Yes