Dexmedetomidine for Shivering During Cesarean Delivery

This study is looking for the best dose of a medicine called dexmedetomidine to stop shivering in patients having a scheduled C-section (cesarean delivery). Shivering can happen during or after surgery. The goal is to find a dose that works for 90% of patients within 5 minutes of getting the medicine. You might be able to join if you are an adult woman having a planned C-section, are generally healthy, and are between 28 and 42 weeks pregnant. You would be enrolled in the study if you experience moderate to severe shivering (Grade 3 or 4) during your delivery. The study is currently unclear on its recruitment status.

Study design
This study plans to enroll 40 women. It uses a special method to adjust the dose of dexmedetomidine to find the most effective amount.
What's involved
You would be recruited before your C-section. If you experience Grade 3 or 4 shivering during delivery, you would receive dexmedetomidine, and your shivering would be checked 5 minutes later.
Compensation
Not stated in the trial record.
Follow-up
Your shivering will be measured 5 minutes after the medicine is given. No other follow-up is specified.

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NCT04730609

Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Recruiting
PHASE4Ages 18+InterventionalTreatment
Mayo Clinic
~40 participants
Updated 2025-09-11 on ClinicalTrials.gov
What's tested:Dexmedetomidine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan
Measured over 5 minutes after administration of the drug
Shivering
Dose Finding Study
1 sites across 1 states
Minnesota1
  • Hans Sviggum, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

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Eligibility criteria

Inclusion

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

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.
  • Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan5 minutes after administration of the drug

    Cessation of shivering