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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sevoflurane-remifentanil (Group SR) | Active Comparator | Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus. |
|
| sevoflurane-saline (Group SS) | Placebo Comparator | Sevoflurane will be initiated, at 8% for anesthesia induction until loss of consciousness will achieve, at which point it will be discontinued. Placebo is 0.9% saline. After the loss of consciousness saline will be administered to Group sevoflurane-saline in the form of intravenous bolus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Anesthetic induction will be achieved via 8% sevoflurane |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Seizure duration | During electroconvulsive therapy | 20 minute |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feray Erdil, MD | Contact | +90 422 341 06 60 | 3148 | feray.erdil@inonu.edu.tr |
| Mahmut Durmus, MD | Contact | +90 422 341 06 60 | 3105 | mahmut.durmus@inonu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Feray Erdil, MD | İnonu Univercity Medical Faculty Department of Anestheisology and Reanimation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turgut Ozal Medical Center | Malatya | 44315 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21116659 | Result | 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: 10.1007/s00540-010-1049-4. Epub 2010 Nov 30. |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D000077208 | Remifentanil |
| D012965 | Sodium Chloride |
| D007552 | Isotonic Solutions |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Remifentanil | Drug | After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus. |
|
|
| Saline | Drug | After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus. |
|
|
| 20 minute |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D011422 | Propionates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |