Recruiting

Dexmedetomidine

Sponsor:

Mayo Clinic

Code:

NCT04730609

Conditions

Shivering

Dose Finding Study

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Dexmedetomidine

Study Details

Brief 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.

Conditions

Shivering

Dose Finding Study

Study ID

NCT04730609

Start date

Sep 21, 2021

Status verified date

Sep, 2025

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dexmedetomidine

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

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 and Locations

Central contacts

Hans P Sviggum, MD

507-293-1169sviggum.hans@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Mickelson Randa

507-284-9697mickelson.randa@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 11, 2025

Last verified

Sep, 2025

Keywords

  • Shivering
  • Cesarean Delivery
  • Dexmedetomidine
  • Dosing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2025-09-11.