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The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Active Comparator | Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus |
|
| Normal saline | Placebo Comparator | NaCl 0,9% 7,5 ml, single intravenous bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | An intravenous bolus of dexmedetomidine 30 mcg (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan. |
| Measure | Description | Time Frame |
|---|---|---|
| Time for cessation of shivering after bolus (min) | Graded on a four point scale as per Crossley and Mahajan | Within the first 15 minutes of administration of bolus |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bradycardia | Heart rate below 50 bpm | From the administration of bolus to the end of surgery, an expected average of 1 hour |
| Incidence of hypotension | A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christina Lamontagne, MD | St. Justine's Hospital | Principal Investigator |
| Chantal Crochetière, MD, FRCP | St. Justine's Hospital | Study Director |
| Edith Villeneuve | St. Justine's Hospital | Study Chair |
| Sandra Lesage | St. Justine's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St-Justine's Hospital | Montreal | Quebec | H3T 1C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25024466 | Background | Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering. Indian J Anaesth. 2014 May;58(3):257-62. doi: 10.4103/0019-5049.135031. | |
| 18433676 | Background | Crowley LJ, Buggy DJ. Shivering and neuraxial anesthesia. Reg Anesth Pain Med. 2008 May-Jun;33(3):241-52. doi: 10.1016/j.rapm.2007.11.006. |
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| ID | Term |
|---|---|
| D014202 | Tremor |
| ID | Term |
|---|---|
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Normal saline | Drug | An intravenous bolus of normal saline (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan. |
|
|
| From the administration of bolus to the end of surgery, an expected average of 1 hour |
| Incidence of sedation | Graded on a four point scale as per Filos et al | From the administration of bolus to the end of surgery, an expected average of 1 hour |
| 8147511 | Background | Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7. doi: 10.1111/j.1365-2044.1994.tb03422.x. |
| 30945105 | Derived | Lamontagne C, Lesage S, Villeneuve E, Lidzborski E, Derstenfeld A, Crochetiere C. Intravenous dexmedetomidine for the treatment of shivering during Cesarean delivery under neuraxial anesthesia: a randomized-controlled trial. Can J Anaesth. 2019 Jul;66(7):762-771. doi: 10.1007/s12630-019-01354-3. Epub 2019 Apr 3. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |