Anesthesia Clinical Trial
Official title:
Inonu University Faculty of Medicine Department of Anesthesiology and Reanimation
NCT number | NCT02819375 |
Other study ID # | Ulku 2 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | January 2017 |
Est. completion date | March 2017 |
Verified date | February 2019 |
Source | Inonu University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Electroconvulsive therapy (ECT) is a common treatment method used in severe depression and
other psychiatric diseases. Currently, most ECT procedures are carried out with muscle
paralysis under general anaesthesia. The anticonvulsant properties of sedative and hypnotic
drugs used during general anaesthesia may reduce the efficacy of ECT. It is important to
establish an accurate balance between adequate anaesthesia depth and optimal seizure
duration.
We aimed to compare the effectiveness of three anaesthetic regimens (propofol alone, propofol
with remifentanil and propofol with ketamine), with respect to seizure duration and seizure
quality in patients undergoing electroconvulsive therapy.
Status | Completed |
Enrollment | 45 |
Est. completion date | March 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Study include 45 patients of American Society of Anesthesiologists (ASA) physical status I-II aged between 18-60 years who scheduled for ECT sessions under general anesthesia Exclusion Criteria: - Pregnancy - Cerebrovascular disease - Epilepsy - Unstable cardiovascular disease - Chronic obstructive pulmonary disease - Renal or hepatic failure |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Inonu University |
Begeç Z, Erdogan Kayhan G, Toprak HI, Sahin T, Konur H, Colak C, Durmus M, Ersoy MO. Sevoflurane alone and propofol with or without remifentanil for electroconvulsive therapy-a randomised, crossover study. Anaesth Intensive Care. 2013 Mar;41(2):202-6. — View Citation
Erdogan Kayhan G, Yucel A, Colak YZ, Ozgul U, Yologlu S, Karlidag R, Ersoy MO. Ketofol (mixture of ketamine and propofol) administration in electroconvulsive therapy. Anaesth Intensive Care. 2012 Mar;40(2):305-10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | seizure activity | Motor (EMG) and electroencephalogram (EEG) seizure durations | intraoperative | |
Secondary | heart rate (HR) | heart rate | (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes | |
Secondary | mean arterial pressure (MAP) | mean arterial pressure | (approximately 10 minutes for all measurements) prior to the seizure, after the anesthetic induction, and following the ECT session at 1 minute, 3 minutes, and 10 minutes | |
Secondary | recovery times | Recovery times will be assessed with spontaneous breathing, eye opening, obeying | intraoperative |
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