RecruitingPhase 4NCT04730609

Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose

Sponsor

Mayo Clinic

Enrollment

40 participants

Start Date

Sep 21, 2021

Study Type

INTERVENTIONAL

Conditions

Shivering Dose Finding Study

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria7

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 Criteria7

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.

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Interventions

DRUGDexmedetomidine

Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect