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compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intranasal dexmedetomidine | Experimental | Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline |
|
| intravenous dexmedetomidine | Experimental | patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intranasal dexmedetomidine | Drug | Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammad F Algyar, MD | Contact | 00201111645345 | 047 | mohammad.algaiar@med.kfs.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Kamal Ebeid, MD | Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mohammad Fouad Algyar | Recruiting | Kafr ash Shaykh | Kafr El-Shaikh | 33516 | Egypt |
The data will be available upon reasonable request from the principal investigator
After one year
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| intravenous dexmedetomidine | Drug | patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline. |
|
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 |