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The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).
Functional endoscopic sinus surgery (FESS) is a well-established therapeutic option for intractable Cytokine release syndrome (CRS) and other indications. Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, the risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid [CSF] leakage, and the duration of surgery increase . Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications .
Increased bleeding sometimes causes surgeries to end before the due time. Improvement of intraoperative visibility while reducing bleeding is an important task for anesthesiologists during Functional endoscopic sinus surgery (FESS).
For this purpose, several pharmaceuticals have been used successfully to produce controlled hypotension during general anesthesia, for example inhalational anesthetics, direct vasodilators (sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol and esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel blockers, prostaglandin E1 (alprostadil) and adenosine and l-receptors agonists (remifentanil) .
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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics. The most common adverse effects associated with Dexmedetomidine include hypotension, bradycardia, and even hypertension.
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 ug/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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal dexmedetomidine group | Experimental | patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline |
|
| intravenous dexmedetomidine group | Experimental | patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal dexmedetomidine group | Drug | patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Formmer's scores of surgical field quality | Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (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) | Intraoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamics effects | Heart rate will be recorded | at baseline and every 5 min till the end of procedure |
| Hemodynamics effects | Mean arterial blood pressure will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad F. Algyar F. Algyar, MD | Contact | 111645345 | +20 | mohammad.algaiar@med.kfs.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Fouad Algyar | Recruiting | Tanta | ElGharbiaa | 31511 | Egypt |
The data will be provided under a reasonable request from the corresponding author.
One year after the end of the study
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| intravouns dexmedetomidine group | Drug | patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline. |
|
| at baseline and every 5 min till the end of procedure |
| Pain level | Pain level will be evaluated using numeric rating analogue scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain. | 24 hour postoperatively |
| Adverse reactions | Adverse reactions of hemostatic stuffing after Functional endoscopic sinus surgery (FESS) will be evaluated. | 24 hour postoperatively |