Three Anaesthesic Method in Electroconvulsive Theraphy

Anesthesia Clinical Trial

Official title:

Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01759589
• Other study ID #: Inonu University Anesthesia
• Secondary ID: Inonu University
• Status: Completed
• Phase: Phase 4
• First received: December 14, 2012
• Last updated: December 31, 2012
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: December 2012
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane in ECT.

Description:

The purpose of this study is to compare the effectiveness of three different anesthetic regimens (propofol, remifentanil-propofol and sevoflurane) with respect to seizure duration, postictal suppression index, early and midictal amplitude, hemodynamic variables and recovery profiles in ECT.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Upremedicated ASA I-II (American Society of Anesthesiologists's physical status) patients,

• Patients scheduled for six ECT sessions for a variety of psychiatric conditions (major depression, schizophrenia)

Exclusion Criteria:

• Involuntary patient status

• Patients with known or self-declared needle or mask phobia

• Pregnancy

• Asthma

• Cerebrovascular disease,

• History of myocardial infarction in the previous 6 months,

• Atrial fibrillation or flutter,heart block,

• A known or family history of reactions to the study drugs.

Study Design

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• Propofol
1 mg/kg propofol IV (over 15 sec) during anesthesia induction
• Remifentanil and propofol
1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
• Sevoflurane
Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered

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)

Toprak HI, Gedik E, Begeç Z, Oztürk E, Kaya B, Ersoy MO. Sevoflurane as an alternative anaesthetic for electroconvulsive therapy. J ECT. 2005 Jun;21(2):108-10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizure duration	After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.	The patients were observed about seizure up to ten minutes after electrical stimulation	Yes
Secondary	postictal suppression index	After anesthesia induction, patients were administered electrical stimulation. Then, postictal suppression index, a parameter that shows seizure quality, was determined from seizure records.	completing seizure in one hour	Yes
Secondary	Recovery parameters (spontaneous breathing, eye opening, and obeying of verbal commands)	The time from the end of succinylcholine administration to the recovery of spontaneous breathing, eye opening, and obeying of verbal commands were recorded.	after seizure in one hour in operation room.	Yes
Secondary	Hemodynamic variables	During perioperative period: Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.	Before administration of the study medications (t0), and at 1 (t1), 3 (t2), and 10 (t3) minutes after the seizure ended.	Yes