Clinical Trials Logo

Clinical 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 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 the investigator will not be aware of the treatment administered.


Clinical Trial 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. At least 100 otosclerosis interventions are performed annually at this clinic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06283836
Study type Interventional
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Caius Mihai Breazu, MD, PhD
Phone +40743010012
Email csbreazu@yahoo.com
Status Not yet recruiting
Phase N/A
Start date March 1, 2024
Completion date March 15, 2025

See also
  Status Clinical Trial Phase
Completed NCT04908839 - Validation of the French Version of the Stapesplasty Outcome Test 25 (SPOT-25)
Completed NCT02901093 - Quantification of Prosthesis Penetration With Conebeam in Otosclerosis N/A
Completed NCT01855425 - Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose N/A
Completed NCT02456272 - Hearing Aid Versus Surgical Rehabilitation as Treatment of Otosclerosis: Pilot Study N/A
Completed NCT00525551 - Efficacy of Acetylcysteine in Patients Undergoing Surgery for Otosclerosis Phase 4
Active, not recruiting NCT00222417 - Audiometric Parameters in Conductive Hearing Loss and Middle Ear Disease Phase 2/Phase 3
Not yet recruiting NCT06022471 - Outcome of Stapes Surgery in Otosclerotic Patients With Tinnitus Using Tinnitogram
Terminated NCT02435446 - Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS) N/A
Terminated NCT01617057 - Therapeutic Efficacy of Tiludronic Acid on Inner Ear Involvement in Advanced Otosclerosis Phase 3
Recruiting NCT05921578 - Cone-beam CT in the Diagnosis and Surgical Treatment of Otosclerosis. N/A
Active, not recruiting NCT05987215 - Interest of Using Deep Learning Algorithm for Otosclerosis Detection on Temporal Bone High Resolution CT
Terminated NCT05214053 - Cone Beam vs MDCT for Diagnosis and Pre-operative Evaluation of Otosclerosis N/A
Completed NCT03888079 - Patient Satisfaction After Surgery for Otosclerosis Under Local ou General Anesthesia
Recruiting NCT06179251 - KNOW HOW TO POSITION THE SACCULE AND UTRICULE IN SCANNING
Completed NCT02019888 - Wide Frequency Band Test of Hearing in Veterans
Not yet recruiting NCT06221007 - Long-Term Results of Bone Cement in Stapes Surgery
Not yet recruiting NCT05799404 - Stapes Footplate Thickness Measured With UHR-CT
Not yet recruiting NCT06323863 - Ultra-high Resolution CT: the End of Stapes Prosthesis Measurement Misestimation