Dexmedetomidine Continuous Intravenous Infusion vs. Remifentanil Target-controlled Infusion Conscious Sedation for Stapedotomy/Stapedectomy- a Prospective, Single-center, Double-masked Randomized Trial

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• otosclerosis surgery, ASA ( American Society of Anesthesiologists) status 1-2

Locations
Other Locations
Romania
Cluj County Clinical Emergency Hospital
Cluj-napoca
Time Frame
Start Date: 2024-03-01
Completion Date: 2025-03-10
Participants
Target number of participants: 74
Treatments
Active_comparator: Group D
Continuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour)
Active_comparator: Group R
Target-controlled infusion of remifentanil ( 2ng//ml- plasma concentration)
Related Therapeutic Areas
Sponsors
Leads: Iuliu Hatieganu University of Medicine and Pharmacy

This content was sourced from clinicaltrials.gov