Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT04730609
Phase
PHASE4
Status
Recruiting
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Conditions

  • Dose Finding Study
  • Shivering

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexmedetomidine — DRUG
    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

Study Details

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.

Key Dates

Start date
Sep 21, 2021
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dexmedetomidine
    IV administration of Dexmedetomidine, using an Up-Down method utilizing a biased coin design to determine that next patient's dose. Initial dose will be 10mcg.

Primary Outcome Measure

Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan [ Time Frame: 5 minutes after administration of the drug ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Mickelson Randa
[email protected]
507-284-9697

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Mayo Clinic in Rochester· Rochester, MN