Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

Otosclerosis Clinical Trial

Official title:

Dexmedetomidine Continuous Intravenous Infusion vs. Remifentanil Target-controlled Infusion Conscious Sedation for Stapedotomy/Stapedectomy- a Prospective, Single-center, Double-masked Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283836
• Other study ID #: Dexrem ATI 4-6
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Otosclerosis

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