Finding the Best Dose of Dexmedetomidine to Stop Shivering During Scheduled Elective Cesarean Delivery

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.

Dexmedetomidine for Intraoperative Shivering in Scheduled Elective Cesarean Delivery