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The purpose of this study to compare the efficacy of intravenous or intrathecal dexmedetomidine on the incidence of shivering on patients who scheduled spinal anesthesia for elective surgery.
The design of the study includes three study groups done in random order. The groups are as follows: 1) Control group received 15 mg levobupivacaine intrathecally and intravenous 0.9% sodium chloride; 2) Intravenous group received 15 mg levobupivacaine intrathecally and intravenous dexmedetomidine (1mcg/kg/10min, 0.5mcg/kg/h infusion) ; 3) Intrathecal group received 15 mg levobupivacaine + 3 mcg dexmedetomidine intrathecally and intravenous 0.9% sodium chloride.
Throughout the study period,shivering scores, tympanic temperature were recorded, heart rate were measured continuously using an electrocardiogram; blood pressure was determined oscillometrically at 5 min intervals at the ankle. In case heart rate decreased by more than 30% of the baseline atropin received and blood pressure decreased 30% of the baseline effedrin received.
Side effects (bradycardia, hypotension, hypothermia, nausea and vomiting etc ) were recorded peroperatively in the operating room and postanesthetic care unit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous | Active Comparator | Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous dexmedetomidine (dexmedetomidine diluted 1mcg/ml and than 1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) |
|
| Intrathecal | Active Comparator | Intrathecal (3 ml) 15 mg levobupivacaine + (0.3 ml) 3 mcg dexmedetomidine (dexmedetomidine diluted 10 mcg/ml) and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion) |
|
| Control | Placebo Comparator | Intrathecal (3 ml) 15 mg levobupivacaine + 0.3 ml 0.9% Sodium chloride and intravenous 0.9% Sodium chloride (1ml/kg/10 minutes and 0.5 ml/kg/hour infusion). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine | Drug | Intrathecal 3ml (15 mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| shivering score | 1 day (From start of anaesthesia till discharge from the recovery room ) |
| Measure | Description | Time Frame |
|---|---|---|
| blood pressure | non invasive blood pressure measured | 1 day (From start of anaesthesia till discharge from the recovery room ) |
| heart rate | 1 day (From start of anaesthesia till discharge from the recovery room ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Resul Altuntas, MD | TC Erciyes University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erciyes University | Kayseri | 38039 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077554 | Levobupivacaine |
| D020927 | Dexmedetomidine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Dexmedetomidine | Drug | Intrathecal 3 microgram (diluted 1/10, 0.3 ml) |
|
|
| Dexmedetomidine | Drug | Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml) |
|
|
| sodium chloride | Drug | Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups. |
|
|
| core temperature | lower than 36 celsius degree was accepted as hypothermia | 1 day (From start of anaesthesia till discharge from the recovery room ) |
| Aniline Compounds |
| D000588 | Amines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |