Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Dexmedetomidine
DrugDoses 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
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: DexmedetomidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
Cessation of shivering
Time frame
5 minutes after administration of the drugSecondary outcomes
1
Maternal Heart Rate
Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.
Time frame
During intraoperative course2
Doses of dexmedetomidine
Determination of the effect of varying doses of dexmedetomidine on maternal sedation.
Time frame
During intraoperative courseSponsors and contacts
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Source ClinicalTrials.gov