Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

NCT ID: NCT06283836

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-03-10

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.

Detailed Description

Otosclerosis has a disabling character through progressive hearing reduction. The etiopathogenetic process consists of osteodystrophy degeneration of the otic capsule, leading to decreased mobility of the stapes bone of the middle ear and causing conductive or mixed hearing loss. It is relatively common in ENT (ear, nose and throat) pathology, generally affecting young adults with a 4:1 ratio between women and men. Treatment is surgical by stapedotomy or stapedectomy and placement of a Teflon prosthesis designed to restore the vibratory capacity of the ossicular complex of the middle ear. Anesthetic management consists, depending on institutional custom, surgeon, or patient preference, in general anesthesia or, relatively frequently, monitored anesthesia care alongside local anesthesia. There is no specific regional anesthesia technique for middle ear interventions because the ear exhibits heterogeneous sensory innervation containing branches from the cervical plexus and cranial nerves V, VII, and X. Local anesthesia consists of circular infiltration of the ear canal and association with an effective sedation technique is indispensable for patient and operator comfort. The objectives of sedation are:

• An immobile operating field.
• Minimal bleeding.
• Hemodynamic and respiratory stability.
• Reducing the risk of postoperative nausea and vomiting.
• Patient comfort. The significant advantage of conscious sedation over general anesthesia or deep sedation is the possibility of real-time feedback from the patient in case of vertigo or for hearing testing after fitting the prosthesis. Deep sedation may also produce an uncooperative patient with involuntary movements or upper airway obstruction under conditions of problematic access to the cephalic extremity that may compromise the operating field.

Dexmedetomidine is a selective alpha-2 adrenergic receptor agonist that appeared in clinical anesthetic practice relatively recently, with sedative effects, reduction of required opioid doses, reduced frequency of delirium and agitation, perioperative sympathicolysis, cardiovascular stabilizing impact and preservation of respiratory function.

Remifentanil is a synthetic, potent, ultrashort-lived opioid used for postoperative analgesia, sedation, or general anesthesia.

The objective of this study is to compare dexmedetomidine (continuous infusion) to remifentanil (target-controlled infusion according to the Minto model) for monitored anesthesia care of a cohort of patients with otosclerosis presenting for stapedectomy/stapedotomy at the ENT Clinic - Cluj County Clinical Emergency Hospital.

Conditions

Otosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Group D

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

monitored anesthesia care (sedation)

Group R

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

Group Type: ACTIVE_COMPARATOR

Remifentanil

Intervention Type: DRUG

monitored anesthesia care (sedation)

Interventions

Dexmedetomidine

monitored anesthesia care (sedation)

Intervention Type: DRUG

Remifentanil

monitored anesthesia care (sedation)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role: lead

Responsible Party

Breazu Caius Mihai

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Caius Mihai Breazu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Iuliu Hatieganu University of Medicine snd Pharmacy

Locations

Cluj County Clinical Emergency Hospital

Cluj-Napoca, Cluj, Romania

Countries

Romania

Other Identifiers

Dexrem ATI 4-6

Identifier Type: -

Identifier Source: org_study_id