Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

Study Overview
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Brief Summary
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Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.

Detailed Description
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Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics.

Official Title
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Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial

Conditions
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Nasal Packing, Dexmedetomidine, Turbinate

Intervention / Treatment
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* Drug: Nasal packing Dexmedetomidine
* Drug: Intravenous Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 years Both sexes American Society of Anesthesiologists (ASA) physical status classification I or II. Undergo turbinate surgery 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. 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 turbinate surgery.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group NP (nasal packing Dexmedetomidine)<br>Patients will receive nasal packing Dexmedetomidine (1.5 mg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline. | Drug: Nasal packing Dexmedetomidine<br>* patients will receive nasal packing Dexmedetomidine (1.5 mg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.<br>|
| Active Comparator: Group IV (Intravenous Dexmedetomidine)<br>Patients will receive 0.5 mg/kg bolus over 10 min then 0.1- 0.4 mg/kg IV infusion Dexmedetomidine and nasal packing with saline. | Drug: Intravenous Dexmedetomidine<br>* patients will receive 0.5 mg/kg bolus over 10 min then 0.1- 0.4 mg/kg Intravenous infusion Dexmedetomidine and nasal packing with saline.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of intraoperative blood loss | Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges. | Intraoperative up to 6hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain) | 24 hours postoperative | 
| Quality of intraoperative surgical field | Quality of intraoperative surgical field during after turbinate surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding) | Intraoperative up to 6hours | 
| Patient's general satisfaction | Patients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of very dissatisfied, dissatisfied, unsure, satisfied, and very satisfied. | 24 hours postoperative |