Status:
RECRUITING
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
Lead Sponsor:
Mayo Clinic
Conditions:
Shivering
Dose Finding Study
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the optimum dose of Dexmedetomidine to stop shivering in 90% of patients who experience shivering during scheduled elective cesarean deliveries.
Detailed Description
Potential subjects will consist of parturients who present for scheduled elective cesarean deliveries. Patients will be recruited and consented for the study pre-operatively and if they display Grade ...
Eligibility Criteria
Inclusion
- Women presenting for planned cesarean delivery.
- American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- Spinal anesthesia technique Women presenting for planned cesarean delivery.
- American Society of Anesthesiology Physical Classification Status 2 or 3; without major medical co-morbidities.
- Singleton gestation in the 3rd trimester (28-42 weeks gestation).
- Spinal anesthesia technique.
Exclusion
- Any contraindication to spinal anesthesia technique.
- Allergy or intolerance to dexmedetomidine or clonidine.
- Oral temperature \< 36° Celsius prior to procedure.
- Unable to give personal consent.
- PPROM or concern for infection (e.g., chorioamnionitis).
- Conversion to General Anesthesia prior to randomization.
- Sedative medications (e.g., fentanyl, midazolam, ketamine, nitrous oxide) administered prior to randomization.
Key Trial Info
Start Date :
September 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04730609
Start Date
September 21 2021
End Date
August 1 2026
Last Update
September 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905