NCT06081933

Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of 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: Phase 4
• Study type: Interventional
• Enrollment: 54 (estimated)
• Sponsor: Kafrelsheikh University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery

Detailed description

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

Conditions

• Dexmedetomidine
• Functional Endoscopic Sinus

Interventions

Type	Name	Description
DRUG	intranasal dexmedetomidine	Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline
DRUG	intravenous dexmedetomidine	patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.

Timeline

• Start date: 2022-12-20
• Primary completion: 2023-12-15
• Completion: 2023-12-15
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: Egypt