NCT04730609 Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
| NCT ID | NCT04730609 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Shivering |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-09-21 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2021-09-21 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Hans Sviggum, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04730609 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Shivering. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04730609 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04730609 currently recruiting?
Yes, NCT04730609 is actively recruiting participants. Contact the research team at sviggum.hans@mayo.edu for enrollment information.
Where is the NCT04730609 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04730609 clinical trial?
NCT04730609 is sponsored by Mayo Clinic. The principal investigator is Hans Sviggum, MD at Mayo Clinic. The trial plans to enroll 40 participants.
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