Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery

Launched by MAYO CLINIC · Jan 28, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a medication called Dexmedetomidine to help prevent shivering in women undergoing scheduled elective cesarean deliveries. Shivering can occur during surgery, and the goal of this study is to find the best dose of Dexmedetomidine that can stop shivering in at least 90% of patients. The trial is currently looking for women aged 18 and older who are scheduled for a cesarean section and are generally healthy, without major medical issues.

If you participate in this study, you can expect to receive either the medication or a placebo (a substance with no active ingredient) during your surgery. To be eligible, you must be having a single baby in your third trimester and plan to use spinal anesthesia for the procedure. However, you won't be able to join if you have any allergies to the medication, cannot give consent, or if your health conditions are not suitable for the study. This trial is important as it aims to improve comfort during cesarean deliveries by reducing shivering, which can be uncomfortable for patients.

Gender

FEMALE

Eligibility criteria

• 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.