Dexmedetomidine vs. Remifentanil Conscious Sedation for Stapedotomy/Stapedectomy

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:

• 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Otosclerosis
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Remifentanil

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

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caius Mihai Breazu, MD, PhD; Phone Number: +40743010012; Email: csbreazu@yahoo.com
• Study Contact Backup: Name: ioan florin marchis, MD, PhD; Phone Number: +40757065205; Email: mosku17@yahoo.com

Study Locations

• Romania
  • Cluj
    • Cluj Napoca, Cluj, Romania, 400006
      • Cluj County Clinical Emergency Hospital
      • Contact: Caius Mihai Breazu, MD, PhD; Phone Number: +40743010012; Email: csbreazu@yahoo.com
      • Contact: ioan florin marchis, MD, PhD; Phone Number: +40757065205; Email: mosku17@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group D; Continuous infusion of dexmedetomidine during intervention ( 1ug/kg over 15 minutes then 0.4 ug/kg/hour)	Drug: Dexmedetomidine; monitored anesthesia care (sedation)
Active Comparator: Group R; Target-controlled infusion of remifentanil ( 2ng//ml- plasma concentration)	Drug: Remifentanil; monitored anesthesia care (sedation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Iowa Satisfaction with Anaesthesia Scale after full recovery. Range between -3 (poor satisfaction) to +3 (very satisfied)	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)	Immediately after procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	the variation of blood pressure during intervention and postoperative	6 hours
Heart Rate	Heart rate variation during intervention and postoperative	6 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
• Investigators: Principal Investigator: Caius Mihai Breazu, MD, PhD, Iuliu Hatieganu University of Medicine snd Pharmacy

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: dexmedetomidine; sedation; remifentanil; satisfaction score; otosclerosis
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otosclerosis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Remifentanil; Dexmedetomidine
• Other Study ID Numbers: Dexrem ATI 4-6

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No