Using Dexmedetomidine to Stop Shivering During Cesarean Deliveries
Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose
This study is testing the best dose of a medication called Dexmedetomidine to see if it can stop shivering in women during scheduled cesarean deliveries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04730609 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the optimal dose of Dexmedetomidine to effectively stop shivering in 90% of patients undergoing scheduled elective cesarean deliveries. Participants will be women who experience significant shivering during the procedure, and the study will utilize a sequential up-and-down dosing method to determine the most effective dose. Anesthesia will be initiated with spinal anesthesia, and shivering will be assessed using a standardized grading scale. The goal is to achieve cessation of shivering within five minutes of administering the medication.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for elective cesarean deliveries who experience significant shivering during the procedure.
Not a fit: Patients who have contraindications to spinal anesthesia or allergies to Dexmedetomidine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide an effective method to manage intraoperative shivering, improving patient comfort and outcomes during cesarean deliveries.
How similar studies have performed: Other studies have explored the use of Dexmedetomidine for sedation and shivering management, showing promising results, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Hans Sviggum, MD — Mayo Clinic
- Study coordinator: Hans P Sviggum, MD
- Email: sviggum.hans@mayo.edu
- Phone: 507-293-1169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.