Clinical trial NCT06081933: Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery
Official title: Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Dexmedetomidine
Functional Endoscopic Sinus
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery

Detailed description: Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.

Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.

Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations

Eligibility criteria: Inclusion Criteria:

* Patients underwent Functional Endoscopic Sinus Surgery
* American Society of Anesthesiologists (ASA) physical status classification I or II

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2 existing or recent significant disease
* contraindications to the use of dexmedetomidine
* history or presence of a significant disease significant cardiovascular disease risk factors
* significant coronary artery disease or any known genetic predisposition
* history of any kind of drug allergy
* drug abuse
* psychological or other emotional problems
* special diet or lifestyle
* clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening
* known systemic disease requiring the use of anticoagulants, patients with a history of previous Functional Endoscopic Sinus Surgery

Primary outcomes:
measure: Improving quality of the operative field
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Heart rate will be evaluated
timeFrame: every 5 min till the end of procedure
measure: Mean arterial blood pressure will be evaluated.
timeFrame: every 5 min till the end of procedure
measure: Pain score will be evaluated.
timeFrame: 24 hour postoperatively
measure: Adverse reactions of hemostatic stuffing after FESS will be evaluated.
timeFrame: 24 hour postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Mohammad Fouad Algyar
state: Kafr El-Shaikh
Study officials:
affiliation: Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt
name: Kamal Ebeid, MD
role: PRINCIPAL_INVESTIGATOR
References: