Actively Recruiting
Dexmedetomidine for Treatment of Shivering During Scheduled Elective Cesarean Delivery: Determining the Optimal Dose
Led by Mayo Clinic · Updated on 2025-09-11
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the best dose of Dexmedetomidine to stop shivering in women undergoing scheduled elective cesarean deliveries. This trial focuses on patients who experience moderate to severe shivering during surgery and aims to find the dose that stops shivering in 90% of these patients within 5 minutes. The study uses a phase 4 design to evaluate this dosing in a real clinical setting. Participants who experience Grade 3 or 4 shivering during their cesarean delivery under spinal anesthesia will receive Dexmedetomidine intravenously. The dose for each patient will be determined using a sequential up-and-down method with a biased coin design, starting with an initial dose of 10 mcg. An anesthesia physician not involved in patient care prepares the drug to maintain objectivity. Spinal anesthesia is given with standard doses of bupivacaine, fentanyl, and morphine. During the study, shivering is graded using a five-point scale from no shivering to full body muscle activity. Researchers will monitor the effect of the drug on shivering within 5 minutes of administration while tracking maternal heart rate and dose amounts during surgery. The trial includes pre-operative screening, drug administration during the operation, and ongoing observation of responses. Participation ends after the intraoperative course, and safety is monitored throughout.
CONDITIONS
Brief Title
Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women presenting for planned cesarean delivery
- American Society of Anesthesiology Physical Classification Status 2 or 3 without major medical co-morbidities
- Singleton pregnancy in the third trimester (28-42 weeks gestation)
- Use of spinal anesthesia technique
You will not qualify if you...
- Contraindication to spinal anesthesia technique
- Allergy or intolerance to dexmedetomidine or clonidine
- Oral temperature below 36 degrees Celsius before the procedure
- Unable to give personal consent
- Preterm premature rupture of membranes or infection concerns such as chorioamnionitis
- Conversion to general anesthesia before randomization
- Use of sedative medications (fentanyl, midazolam, ketamine, nitrous oxide) before randomization
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - During the intraoperative course
Participants receive intravenous dexmedetomidine during scheduled elective cesarean delivery if they experience Grade 3 or 4 shivering at delivery. The dose is adjusted using a sequential up-and-down method to find the optimal dose for stopping shivering within 5 minutes.
1 treatment visit (in-person) during cesarean delivery
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
H
Hans P Sviggum, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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