drugset / Trial / NCT06283836

Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

NCT06283836 ↗

RandomizedParallel-groupTriple-blindSupportive care

Summary

Dexmedetomidine continuous intravenous infusion vs. remifentanil target-controlled infusion conscious sedation for stapedotomy/stapedectomy- a prospective, single-center, double-masked randomized trial The goal of this clinical trial is to compare monitored anesthesia care with continuous intravenous dexmedetomidine vs. remifentanil target-controlled infusion in patients undergoing stapedotomy or stapedectomy for otosclerosis. The aims of this research are: * to assess the patient's satisfaction with each sedation regimen * the surgeon will also grade their satisfaction regarding the surgical field The investigators will monitor and analyze the vitals during and after the intervention and document any intra- and postoperative complications. Participants will be randomly assigned to receive either dexmedetomidine or remifentanil, and the patient, the surgeon, and other care providers except the attending anesthesiologist will not be aware of the treatment administered.

Timeline

Start
2024-03-01
Primary completion
2025-03-01
Completion
2025-03-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexmedetomidine Other / unclassified 0.4 ug/kg Intravenous
Comparator Remifentanil Small molecule 2 ng/ml —

Indications