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
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:
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.
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:
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.
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 →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.
Exclusion Criteria:
Continuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour)
Drug: Dexmedetomidine
Target-controlled infusion of remifentanil ( 2ng//ml- plasma concentration)
Drug: Remifentanil
monitored anesthesia care (sedation)
monitored anesthesia care (sedation)
Patient satisfaction
Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied)
Time frame: 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)
Time frame: Immediately after procedure
mean arterial pressure
the variation of blood pressure during intervention and postoperative
Time frame: 6 hours
Heart Rate
Heart rate variation during intervention and postoperative
Time frame: 6 hours
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
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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Iuliu Hatieganu University of Medicine and Pharmacy