The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy

Haemodynamic Rebound Clinical Trial

Official title:

Inonu University, Turgut Ozal Medical Center, Department of Anesthesiology and Reanimation Malatya

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02271555
• Other study ID #: Inonu 3
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 16, 2014
• Last updated: October 20, 2014
• Start date: October 2014
• Est. completion date: December 2014

Study information

• Verified date: October 2014
• Source: Inonu University
• Contact: Feray Erdil, MD
• Phone: +90 422 341 06 60
• Email: feray.erdil[@]inonu.edu.tr
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression

Description:

Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 58
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Major depressive patients

Exclusion Criteria:

• younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.

Study Design

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

Related Conditions & MeSH terms

• Haemodynamic Rebound

Intervention

Drug:
• Sevoflurane
Anesthetic induction will be achieved via 8% sevoflurane
• Remifentanil
After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
• Saline
After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.

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)

Nishikawa K, Higuchi M, Kawagishi T, Shimodate Y, Yamakage M. Effect of divided supplementation of remifentanil on seizure duration and hemodynamic responses during electroconvulsive therapy under propofol anesthesia. J Anesth. 2011 Feb;25(1):29-33. doi: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effects of remifentanil on the heart rate after electroconvulsive therapy	Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).	20 minute	Yes
Secondary	Seizure duration	During electroconvulsive therapy	20 minute	Yes
Secondary	The effects of remifentanil on the mean arterial pressure after electroconvulsive therapy	Prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively).	20 minute	Yes