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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06283836
Other study ID # Dexrem ATI 4-6
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date March 15, 2025

Study information

Verified date February 2024
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Caius Mihai Breazu, MD, PhD
Phone +40743010012
Email csbreazu@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date March 15, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
monitored anesthesia care (sedation)
Remifentanil
monitored anesthesia care (sedation)

Locations

Country Name City State
Romania Cluj County Clinical Emergency Hospital Cluj Napoca Cluj

Sponsors (1)

Lead Sponsor Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type Measure Description Time frame Safety issue
Other 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 during surgery
Primary Patient satisfaction Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied) 24 hours
Primary Surgeon satisfaction Surgeon satisfaction score to be assessed on a 1-4 VAS after the procedure ( 1-poor, 2-moderate, 3-good, 4-excellent) Immediately after procedure
Secondary mean arterial pressure the variation of blood pressure during intervention and postoperative 6 hours
Secondary Heart Rate Heart rate variation during intervention and postoperative 6 hours
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