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NCT Number: NCT04730609

Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Mickelson Randa

CONTACT

[email protected]

507-284-9697

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Shivering will be graded using a five-point scale as outlined by Crossley and Mahajan

    Time frame: 5 minutes after administration of the drug

    Cessation of shivering

Secondary outcomes

  1. Maternal Heart Rate

    Time frame: During intraoperative course

    Determination of the effect of varying doses of dexmedetomidine on maternal heart rate.

  2. Doses of dexmedetomidine

    Time frame: During intraoperative course

    Determination of the effect of varying doses of dexmedetomidine on maternal sedation.

Study contacts

Contact information is provided by the study sponsor or research team.

Hans P Sviggum, MD

CONTACT

[email protected]

507-293-1169

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2021
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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