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Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

NCT06283836 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-04-01

No results posted yet for this study

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.

Conditions

  • Otosclerosis

Interventions

DRUG

Dexmedetomidine

monitored anesthesia care (sedation)

DRUG

Remifentanil

monitored anesthesia care (sedation)

Sponsors & Collaborators

  • Iuliu Hatieganu University of Medicine and Pharmacy

    lead OTHER

Principal Investigators

  • Caius Mihai Breazu, MD, PhD · Iuliu Hatieganu University of Medicine snd Pharmacy

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06283836 on ClinicalTrials.gov