Three Anaesthesic Method in Electroconvulsive Theraphy

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Propofol; Drug: Remifentanil and propofol; Drug: Sevoflurane

• Registration Number: NCT01759589
• Lead Sponsor: Inonu University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2012-12
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-31
• Last Update Submitted: 2012-12-31
• Study First Posted: 2013-01-03
• Last Update Posted: 2013-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
propofol (Group P)	Propofol	The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction
remifentanil and propofol (Group R)	Remifentanil and propofol	Patients in Group R received remifentanil 1 µg/kg IV (over 60 sec) and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
sevoflurane (Group S)	Sevoflurane	In Group S, sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered, at which time it was stopped.

Primary Outcome Measures

Name	Time	Method
Seizure duration	The patients were observed about seizure up to ten minutes after electrical stimulation	After anesthesia induction patients were administered electrical stimulation and seizure duration were measured.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Turgut Ozal Medical Center; 🇹🇷 Malatya, Turkey