Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Location status: Recruiting
NCT Number: NCT04730609
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.
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Rochester, Minnesota, 55905, United States
Location status: Recruiting
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 3 or 4 shivering at the time of delivery then they will be enrolled in the study. 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 - cessation of shivering within 5 minutes of medication administration. An anesthesia physician not involved in patient care or assessment will prepare the dexmedetomidine for intravenous use. Anesthesia will be initiated with spinal anesthesia with our institution's typical dosing of 1.6 mL 0.75% bupivacaine with dextrose, 15 mcg fentanyl, and 150 mcg morphine.
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan. Members of the anesthesia team caring for women in the study will be educated on the grading scales.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 5 minutes after administration of the drug
Cessation of shivering
Time frame: During intraoperative course
Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.
Time frame: During intraoperative course
Determination of the effect of varying doses of dexmedetomidine on maternal sedation.
Contact information is provided by the study sponsor or research team.
Mayo Clinic
Other
Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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