Tremor
Conditions
Keywords
Dexmedetomidine, Cesarean section, Anesthesia, Spinal, Anesthesia, Epidural
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.
Interventions
DRUGDexmedetomidine
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.
DRUGNormal 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.
Sponsors
St. Justine's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed