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New treatment option for Shivering
Official title Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery
ClinicalTrials.gov ID: NCT04730609
What this study is testing
What is Dexmedetomidine?
Dexmedetomidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for shivering.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.