Clinical trial NCT02384343: Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia
Official title: Intravenous Dexmedetomidine for Treatment of Shivering During Cesarean Section Under Neuraxial Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tremor
Keywords: Dexmedetomidine
Cesarean section
Anesthesia, Spinal
Anesthesia, Epidural
Lead sponsor: St. Justine's Hospital
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.
* Participants with fever or shivering before the cesarean section are include

Exclusion Criteria:

* No comprehension of french or english language
* 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

Primary outcomes:
measure: Time for cessation of shivering after bolus (min)
timeFrame: Within the first 15 minutes of administration of bolus
Secondary outcomes:
measure: Incidence of bradycardia
timeFrame: From the administration of bolus to the end of surgery, an expected average of 1 hour
measure: Incidence of hypotension
timeFrame: From the administration of bolus to the end of surgery, an expected average of 1 hour
measure: Incidence of sedation
timeFrame: From the administration of bolus to the end of surgery, an expected average of 1 hour
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: St-Justine's Hospital
state: Quebec
Study officials:
affiliation: St. Justine's Hospital
name: Christina Lamontagne, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Justine's Hospital
name: Chantal Crochetière, MD, FRCP
role: STUDY_DIRECTOR
affiliation: St. Justine's Hospital
name: Edith Villeneuve
role: STUDY_CHAIR
affiliation: St. Justine's Hospital
name: Sandra Lesage
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.