Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

NCT06283836 | Completed

• 1 other identifier: Dexrem ATI 4-6
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

otosclerosis; dexmedetomidine; remifentanil; sedation; satisfaction score

Outcome Measures

Primary Outcomes (2)

• Patient satisfaction

  Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied)

  24 hours

• Surgeon satisfaction

  Surgeon satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent)

  Immediately after procedure

Secondary Outcomes (2)

• mean arterial pressure

  6 hours

• Heart Rate

  6 hours

Other Outcomes (1)

• the need for adjuncts during intervention

  during surgery

Study Arms (2)

Group D

ACTIVE COMPARATOR

Continuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour)

Drug: Dexmedetomidine

Group R

ACTIVE COMPARATOR

Target-controlled infusion of remifentanil ( 2ng//ml- plasma concentration)

Drug: Remifentanil

Interventions

Dexmedetomidine DRUG

monitored anesthesia care (sedation)

Group D

Remifentanil DRUG

monitored anesthesia care (sedation)

Group R

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA status 3-4
• requiring general anesthesia
• refusing to participate
• allergic to study medication
• severe bradicardia, atrioventricular block
• cognitive impairment

Sponsors & Collaborators

• Iuliu Hatieganu University of Medicine and Pharmacy: lead

Study Sites (1)

Cluj County Clinical Emergency Hospital

Cluj-Napoca, Cluj, 400006, Romania

Location

MeSH Terms

Conditions

Otosclerosis

Interventions

Dexmedetomidine; Remifentanil

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Study Officials

• Caius Mihai Breazu, MD, PhD

  Iuliu Hatieganu University of Medicine snd Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients and surgeons were blinded to the group allocation and the personnel providing postoperative care and collecting the postoperative data were also unaware of the group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 10, 2025
• Last Updated: April 1, 2025

Record last verified: 2024-08

Locations

RO (1)