Cesarean Section Complications
Conditions
Brief summary
Comparing two treatments for shivering after cesarean delivery for labor dystocia under epidural anesthesia.
Detailed description
It is a double blinded randomized control trial. Study population: parturients undergoing a cesarean delivery for labor dystocia under epidural anesthesia experiencing shivering grade III or IV on the standardized shivering scale of Crossley and Mahajan Experimental group: dexmedetomidine 0.35 mcg/kg IV in 2 minutes Control group: meperidine 0.35 mg/kg IV in 2 minutes Primary outcome : Time to stop level III and IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug Secondary outcome: Response rate, incidence of nausea, vomiting, hypotension, bradycardia, maternal satisfaction and a cost-benefit analysis. The hypothesis is that dexmedetomidine will act faster, will have a superior response rate with less adverse effects.
Interventions
DRUGDexmedetomidine Injection
0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
DRUGMeperidine Injection
0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blinded randomized study: meperidine and dexmedetomidine will be prepared at the hospital pharmacy in a 10 mL seringue with equivalent dilution in order to gave mL/kg.
Intervention model description
Comparing two groups: experimental (dexmedetomidine) versus control (meperidine)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Term \> 37 weeks * American Society of Anesthesiologists Physical Status (ASA PS) I, II * Weight \< 115 kg * Functional epidural in situ * In labor requiring cesarean delivery * Class III or IV shivering on the Crossley and Mahajan standardized shivering scale between five minutes after the baby's birth to the end of the cesarean section
Exclusion criteria
* Refusal of the patient and/or the anesthesiologist * Misunderstanding of the protocol * Known allergy or contraindication to one of the study drugs * Emergency cesarean delivery * American Society of Anesthesiologists Physical Status III, IV, V * Severe heart, liver or kidney disease, * Preeclampsia * Patient taking monoamine oxydase inhibitors * Sleep apnea * General anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stop time | 15 minutes | Time to stop class III or IV shivering on the Crossley and Mahajan standardized shivering scale after the administration of the study drug (meperidine versus dexmedetomidine) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of adverse effects | 24 hours | sedation, nausea, vomiting, hypotension and bradycardia |
| maternal satisfaction | at 24 hours | satisfaction (yes or no) regarding experience with study drug |
| response rate | 15 minutes | percentage of patient responding when the drug is given |
| cost benefice analysis | 24 hours | comparing cost of the drug |
Countries
Canada
Outcome results
None listed