Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06283836
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2024-02-14
Brief Title:
Dexmedetomidine vs Remifentanil Conscious Sedation for StapedotomyStapedectomy
Sponsor:
Iuliu Hatieganu University of Medicine and Pharmacy
Organization:
Iuliu Hatieganu University of Medicine and Pharmacy
Study Overview
Official Title:
Dexmedetomidine Continuous Intravenous Infusion vs Remifentanil Target-controlled Infusion Conscious Sedation for StapedotomyStapedectomy- a Prospective Single-center Double-masked Randomized Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Dexmedetomidine continuous intravenous infusion vs remifentanil target-controlled infusion conscious sedation for stapedotomystapedectomy- 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 patients 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
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 patients 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
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 41 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 stapedectomystapedotomy at the ENT Clinic - Cluj County Clinical Emergency Hospital At least 100 otosclerosis interventions are performed annually at this clinic
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 stapedectomystapedotomy at the ENT Clinic - Cluj County Clinical Emergency Hospital At least 100 otosclerosis interventions are performed annually at this clinic
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None