NCT05595083

Intranasal vs. IV Dexmedetomidine in Endoscopic Sinus Surgery

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Functional Endoscopic Sinus Surgery
• Dexmedetomidine

Interventions

Type	Name	Description
DRUG	intranasal dexmedetomidine group	patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline
DRUG	intravouns dexmedetomidine group	patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-10-01
• Completion: 2023-10-01
• First posted: 2022-10-26
• Last updated: 2023-09-06

Locations

1 site across 1 country: Egypt