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CompletedNCT06283836Updated Apr 1, 2025

Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

An interventional study of Dexmedetomidine and Remifentanil in Otosclerosis, sponsored by Iuliu Hatieganu University of Medicine and Pharmacy. Completed at 1 site in Romania. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Iuliu Hatieganu University of Medicine and Pharmacy · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Otosclerosis

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Keywords

  • otosclerosis
  • dexmedetomidine
  • remifentanil
  • sedation
  • satisfaction score
03

In context

Otosclerosis

23 studies on the registry are indexed under Otosclerosis; 5 are open to participants now.

This study's enrollment of 74 is above the median of 32 across 10 interventional studies indexed under Otosclerosis.

Browse Otosclerosis studies →

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy is the lead sponsor of 53 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • ASA status 3-4
  • requiring general anesthesia
  • refusing to participate
  • allergic to study medication
  • severe bradicardia, atrioventricular block
  • cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • Active comparator
    Group D

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

    Drug: Dexmedetomidine

  • Active comparator
    Group R

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

    Drug: Remifentanil

Interventions

  • DrugDexmedetomidine

    monitored anesthesia care (sedation)

  • DrugRemifentanil

    monitored anesthesia care (sedation)

06

What researchers measure

Primary outcomes

  1. Patient satisfaction

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

    Time frame: 24 hours

  2. Surgeon satisfaction

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

    Time frame: Immediately after procedure

Secondary outcomes

  1. mean arterial pressure

    the variation of blood pressure during intervention and postoperative

    Time frame: 6 hours

  2. Heart Rate

    Heart rate variation during intervention and postoperative

    Time frame: 6 hours

Other outcomes

  1. the need for adjuncts during intervention

    insufficient sedation grade or analgesia requiring administration of hypnotics or opioids beyond the protocol to maintain an adequate level of comfort for patient and surgeon

    Time frame: during surgery

07

Study locations

1 site
  • Cluj County Clinical Emergency Hospital
    Cluj Napoca, Cluj 400006, Romania
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06283836
Lead sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
Responsible party
Breazu Caius Mihai (MD, PhD, Iuliu Hatieganu University of Medicine and Pharmacy) — Principal investigator
First posted
Feb 28, 2024
Start date
Mar 1, 2024
Primary completion
Mar 1, 2025
Completion
Mar 10, 2025
Last update
Apr 1, 2025

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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