Three Anaesthesic Method in Electroconvulsive Theraphy
|ClinicalTrials.gov Identifier: NCT01759589|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : January 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Anesthesia||Drug: Propofol Drug: Remifentanil and propofol Drug: Sevoflurane||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Sevoflurane Alone and Propofol With or Without Remifentanil in Electroconvulsive Therapy|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||August 2011|
Placebo Comparator: propofol (Group P)
The patients in Group P received 1 mg/kg propofol IV (over 15 sec) during anesthesia induction
1 mg/kg propofol IV (over 15 sec) during anesthesia induction
Other Name: Intravenous anesthetic agent
Active Comparator: remifentanil and propofol (Group R)
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
Drug: Remifentanil and propofol
1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
Other Name: Opioid and intravenous anesthetic agent
Active Comparator: sevoflurane (Group S)
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.
Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered
Other Name: Volatil anesthetic
- Seizure duration [ Time Frame: 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.
- postictal suppression index [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759589
|Turgut Ozal Medical Center|
|Malatya, Turkey, 44315|
|Study Director:||Zekine Begec|