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Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.
Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal dexmedetomidine group | Active Comparator | 30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline. |
|
| Intravenous dexmedetomidine group | Active Comparator | 30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + intranasal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal dexmedetomidine | Drug | 45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline |
| Measure | Description | Time Frame |
|---|---|---|
| Improving quality of the operative field. | Quality of intraoperative surgical field during functional endoscopic sinus 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. | during surgery (intraoperatively) 2 hours |
| Amount of atropine consumption | The total amount of atropine consumed will be recorded | First 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Hemodynamics(Heart rate (bpm)) | Heart rate (bpm), at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery. | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facualty of Medicine(Damietta), Al Azhar University | Damietta | 34711 | Egypt |
data can be shared with a reasonable request from the corresponding author
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| D005283 | Fentanyl |
| D007530 | Isoflurane |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
| Intravenous dexmedetomidine | Drug | patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline. |
|
|
| Hemodynamics(Mean arterial blood pressure mm Hg)) |
Mean arterial blood pressure mm Hg) at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery. |
| 2 hours |
| Pain score | Pain measured with VAS: (visual analogue scale) will be assessed in post anesthesia care unit, 1, 2, 4, 6, 8, 12, 18, and 24hours postoperative. The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). patients are asked to rate their current level of pain by placing a mark on the line. | First 24 hours postoperatively |
| Adverse events | Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia. | 24 postoperatively |
| hemostatic stuffing | The degree of adverse reactions of hemostatic stuffing after functional endoscopic sinus surgery will be also evaluated (1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate). | 24 hours postoperatively |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |