Dexmedetomidine for Surgical Shivering
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does exclude those who have taken sedative medications like fentanyl, midazolam, ketamine, or nitrous oxide before randomization.
What data supports the effectiveness of the drug Dexmedetomidine for surgical shivering?
Is dexmedetomidine safe for humans?
How does the drug dexmedetomidine differ from other treatments for surgical shivering?
Dexmedetomidine is unique because it is an alpha-2 adrenergic agonist (a type of drug that affects certain receptors in the brain) that not only helps reduce shivering but also acts as a sedative, which can be beneficial during surgery. Unlike other treatments, it lowers the shivering threshold, making it effective in preventing and treating shivering after anesthesia.24589
Research Team
Hans Sviggum, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for women having a planned cesarean delivery under spinal anesthesia, with an ASA status of 2 or 3 and no major health issues. They must be in their third trimester without signs of infection or preterm rupture of membranes (PPROM), able to consent, and not have taken certain sedatives or have allergies to dexmedetomidine.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dexmedetomidine to treat shivering during cesarean delivery
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Dexmedetomidine
Dexmedetomidine is already approved in European Union, United States, Canada, Japan for the following indications:
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
- Sedation in intensive care settings
- Procedural sedation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor