Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
NCT ID: NCT02384343
Last Updated: 2018-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2015-04-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dexmedetomidine
Dexmedetomidine 4 mcg/ml, 30 mcg (7,5 ml), single intravenous bolus
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.
Normal saline
NaCl 0,9% 7,5 ml, single intravenous bolus
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with fever or shivering before the cesarean section are include
Exclusion Criteria
* Urgent cesarean delivery for non reassuring fetal tracing
* Extremely urgent cesarean delivery (grade 1)
* Weight \< 60 kg ou \> 120 kg
* Hypersensibility to dexmedetomidine
* Heart, renal or hepatic disease requiring follow up, medication or with a possibility of instability during cesarean delivery
* Pre-eclampsia
* Combined spinal-epidural anesthesia
* Conversion into general anesthesia
* Blood products transfusions or major complications during surgery
18 Years
FEMALE
No
Sponsors
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St. Justine's Hospital
OTHER
Responsible Party
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Christina Lamontagne
MD
Principal Investigators
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Christina Lamontagne, MD
Role: PRINCIPAL_INVESTIGATOR
St. Justine's Hospital
Chantal Crochetière, MD, FRCP
Role: STUDY_DIRECTOR
St. Justine's Hospital
Edith Villeneuve
Role: STUDY_CHAIR
St. Justine's Hospital
Sandra Lesage
Role: STUDY_CHAIR
St. Justine's Hospital
Locations
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St-Justine's Hospital
Montreal, Quebec, Canada
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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050115
Identifier Type: -
Identifier Source: org_study_id
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