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The investigators evaluate the effects of a subanesthetic dose of ketamine, administered as an adjunct to sevoflurane, on duration of seizure activity, hemodynamic profile and recovery times during electroconvulsive therapy (ECT) in patients with major depression.
Patients will randomly allocate, to either a sevoflurane-ketamine (Group SK), sevoflurane-saline (Group SS) receiving group. Mean arterial pressure (MAP) and heart rate (HR) will record prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). Motor and EEG seizure durations will be recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group SK | Active Comparator | Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Following loss of consciousness ketamine was administered to Group SK (n=29) in the form of a 0.5mg/kg iv bolus. Patients in Group SS (n=30) received saline in the same manner. |
|
| Group SS | Placebo Comparator | Sevoflurane was initiated, in both groups, at 8% for anesthesia induction until loss of consciousness was achieved, at which point it was discontinued. Patients in Group SS (n=30) received saline in the same manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane | Drug | Inhalation anesthetic agent |
|
| Measure | Description | Time Frame |
|---|---|---|
| seizure duration | the time from application of the ECT stimulus to the cessation of tonic-clonic motor activity in the isolated arm. | During electroconvulsive therapy (30 minutes) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean arterial pressure (MAP) | Mean arterial pressure (MAP) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). | During Electroconvulsive therapy (30 minutes) |
| Heart rate (HR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feray Erdil, MD | Contact | 904223410660 | 3148 | feray.erdil@inonu.edu.tr |
| Mahmut Durmus, MD | Contact | 904223410660 | 3105 | mahmut.durmus@inonu.edu.tr |
| Name | Affiliation | Role |
|---|---|---|
| Feray Erdil, MD | MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Turgut Ozal Medical Center | Recruiting | Malatya | 44315 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22623080 | Result | Yalcin S, Aydogan H, Selek S, Kucuk A, Yuce HH, Karababa F, Bilgic T. Ketofol in electroconvulsive therapy anesthesia: two stones for one bird. J Anesth. 2012 Aug;26(4):562-7. doi: 10.1007/s00540-012-1378-6. Epub 2012 May 24. |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D007649 | Ketamine |
| D007267 | Injections |
| D012965 | Sodium Chloride |
| D007552 | Isotonic Solutions |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
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| Ketamine | Drug | Intravenous anesthetic agent |
|
|
| Saline | Drug | Isotonic solution for placebo group |
|
|
Heart rate (HR) will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 min after the seizure has ended (T3, T4, T5, and T6, respectively). |
| During Electroconvulsive therapy (30 minutes) |
| D006846 |
| Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |