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Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Shivering Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 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. - Grade 0: no shivering; - Grade 1: one or more of the following: piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity; Grade 2: visible muscle activity confined to one muscle group; - Grade 3: visible muscle activity in more than one muscle group; - Grade 4: gross muscle activity involving the whole body ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04730609
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 4
Start date September 21, 2021
Completion date August 2024
View Details
See also
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