OtosclerosisNCT06283836
Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy
A study testing Dexmedetomidine and Remifentanil in people with Otosclerosis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Otosclerosis
- What is being tested?
- Dexmedetomidine and Remifentanil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteRomania
- Study dates
- 1 Mar 2024to 10 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- otosclerosis surgery, ASA ( American Society of Anesthesiologists) status 1-2
Who cannot join
- ASA status 3-4
- requiring general anesthesia
- refusing to participate
- allergic to study medication
- severe bradicardia, atrioventricular block
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
Romania1 site
Cluj County Clinical Emergency Hospital
Cluj-Napoca, Cluj, 400006
About this study
Official title: Dexmedetomidine Continuous Intravenous Infusion vs. Remifentanil Target-controlled Infusion Conscious Sedation for Stapedotomy/Stapedectomy- a Prospective, Single-center, Double-masked Randomized Trial
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:
Read more
- 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.
- Conditions
- Otosclerosis
- Being tested
- Dexmedetomidine, Remifentanil
- Keywords
- otosclerosis, dexmedetomidine, remifentanil, sedation, satisfaction score
- Medical subject headings
- Otosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
monitored anesthesia care (sedation)
RemifentanilDrug
monitored anesthesia care (sedation)
| Study group | Role | What they receive |
|---|---|---|
| Group D | Active comparator | Continuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour) Receives: Drug: Dexmedetomidine |
| Group R | Active comparator | Target-controlled infusion of remifentanil ( 2ng//ml- plasma concentration) Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied)
Measured: 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)
Measured: Immediately after procedure
Secondary outcomes (2)
mean arterial pressure
the variation of blood pressure during intervention and postoperative
Measured: 6 hours
Heart Rate
Heart rate variation during intervention and postoperative
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion10 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breazu Caius Mihai, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Caius Mihai Breazu, MD, PhD, Principal investigator, Iuliu Hatieganu University of Medicine snd Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283836
- Sponsor's protocol ID
- Dexrem ATI 4-6
- Status last verified
- Aug 2024
- First submitted
- 14 Feb 2024
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Continuous Intravenous Infusion vs. Remifentanil Target-controlled Infusion Conscious Sedation for Stapedotomy/Stapedectomy- a Prospective, Single-center, Double-masked Randomized Trial
- ClinicalTrials.gov ID
- NCT06283836
- Acronym / sponsor ID
- Dexrem ATI 4-6
- Conditions
- Otosclerosis
- Keywords
- otosclerosis, dexmedetomidine, remifentanil, sedation, satisfaction score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 10 Mar 2025 (actual)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Active comparator | Drug: DexmedetomidineContinuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour) |
| Group R | Active comparator | Drug: RemifentanilTarget-controlled infusion of remifentanil ( 2ng//ml- plasma concentration) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- otosclerosis surgery, ASA ( American Society of Anesthesiologists) status 1-2
Key exclusion criteria (6 listed)
- ASA status 3-4
- requiring general anesthesia
- refusing to participate
- allergic to study medication
- severe bradicardia, atrioventricular block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidinemonitored anesthesia care (sedation) | Drug | Group D |
| Remifentanilmonitored anesthesia care (sedation) | Drug | Group R |
Primary outcome
Patient satisfaction
Time frame: 24 hours
Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied)
Surgeon satisfaction
Time frame: Immediately after procedure
Surgeon satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent)
2 secondary outcomes
mean arterial pressure
Time frame: 6 hours
Heart Rate
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
Related trials for Otosclerosis
Active, not recruiting
Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis.
Otosclerosis, Cone Beam Computed Tomography
Not yet recruiting
Surgical and Audiological Outcomes of Endoscopic Stapes Surgery
Otosclerosis
RecruitingObservational study
Investigating the Relationship Between Temporal Bone CT, Bone Density, and Hearing Loss in Otosclerosis Patients
Otosclerosis of Middle Ear, Bone Density
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caius Mihai Breazu, MD, PhD principal investigator
Iuliu Hatieganu University of Medicine snd Pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine and Remifentanil in people with Otosclerosis, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.