Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether dexmedotomidine is effective in the treatment of shivering associated with neuraxial anesthesia during cesarean delivery.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Dexmedetomidine Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus |
Drug: Dexmedetomidine
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.
Other Names:
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| Placebo Comparator: Normal saline NaCl 0,9% 7,5 ml, single intravenous bolus |
Drug: Normal saline
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Time for cessation of shivering after bolus (min) [Within the first 15 minutes of administration of bolus]
Graded on a four point scale as per Crossley and Mahajan
Secondary Outcome Measures
- Incidence of bradycardia [From the administration of bolus to the end of surgery, an expected average of 1 hour]
Heart rate below 50 bpm
- Incidence of hypotension [From the administration of bolus to the end of surgery, an expected average of 1 hour]
A decrease in mean arterial pressure by more than 20% of the baseline mean arterial pressure
- Incidence of sedation [From the administration of bolus to the end of surgery, an expected average of 1 hour]
Graded on a four point scale as per Filos et al
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cesarean delivery under neuraxial anesthesia (epidural or spinal) planned or unplanned between 8 am and 8 pm on week days when one of the investigator is present.
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Participants with fever or shivering before the cesarean section are include
Exclusion Criteria:
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No comprehension of french or english language
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Urgent cesarean delivery for non reassuring fetal tracing
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Extremely urgent cesarean delivery (grade 1)
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Weight < 60 kg ou > 120 kg
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Hypersensibility to dexmedetomidine
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Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
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Pre-eclampsia
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Combined spinal-epidural anesthesia
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Conversion into general anesthesia
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Blood products transfusions or major complications during surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St-Justine's Hospital | Montréal | Quebec | Canada | H3T 1C4 |
Sponsors and Collaborators
- St. Justine's Hospital
Investigators
- Principal Investigator: Christina Lamontagne, MD, St. Justine's Hospital
- Study Director: Chantal Crochetière, MD, FRCP, St. Justine's Hospital
- Study Chair: Edith Villeneuve, St. Justine's Hospital
- Study Chair: Sandra Lesage, St. Justine's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Crossley AW, Mahajan RP. The intensity of postoperative shivering is unrelated to axillary temperature. Anaesthesia. 1994 Mar;49(3):205-7.
- 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. Review.
- 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.
- 050115