Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery

Study Overview
=================
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

Official Title
-----------------
Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial

Conditions
-----------------
Dexmedetomidine, Functional Endoscopic Sinus

Intervention / Treatment
-----------------
* Drug: intranasal dexmedetomidine
* Drug: intravenous dexmedetomidine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intranasal dexmedetomidine<br>Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline | Drug: intranasal dexmedetomidine<br>* Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline<br>|
| Experimental: intravenous dexmedetomidine<br>patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline. | Drug: intravenous dexmedetomidine<br>* patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving quality of the operative field | Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of very dissatisfied, dissatisfied, unsure, satisfied, and very satisfied. | 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate will be evaluated | Heart rate will be recorded at baseline and every 5 min till the end of procedure | every 5 min till the end of procedure | 
| Mean arterial blood pressure will be evaluated. | Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure | every 5 min till the end of procedure | 
| Pain score will be evaluated. | Pain score will be evaluated measured with Numerical rating scale The numerical scale is most commonly 0 to 10, with 0 being no pain and 10 being the worst pain imaginable | 24 hour postoperatively | 
| Adverse reactions of hemostatic stuffing after FESS will be evaluated. | 1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate | 24 hour postoperatively |