Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery

Phase 4

Recruiting

• Conditions: Functional Endoscopic Sinus; Dexmedetomidine
• Interventions: Drug: intranasal dexmedetomidine; Drug: intravenous dexmedetomidine

• Registration Number: NCT06081933
• Lead Sponsor: Kafrelsheikh University

Brief 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

Study Timeline

• Study First Submitted: 2022-12-11
• Study Start: 2022-12-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-10-07
• Last Update Submitted: 2023-10-07
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2023-12-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients underwent Functional Endoscopic Sinus Surgery
• American Society of Anesthesiologists (ASA) physical status classification I or II

Exclusion Criteria

• Patients with a body mass index > 30 kg/m2 existing or recent significant disease
• contraindications to the use of dexmedetomidine
• history or presence of a significant disease significant cardiovascular disease risk factors
• significant coronary artery disease or any known genetic predisposition
• history of any kind of drug allergy
• drug abuse
• psychological or other emotional problems
• special diet or lifestyle
• clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening
• known systemic disease requiring the use of anticoagulants, patients with a history of previous Functional Endoscopic Sinus Surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improving quality of the operative field	24 hours postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Heart rate will be evaluated	every 5 min till the end of procedure	Heart rate will be recorded at baseline and every 5 min till the end of procedure
Mean arterial blood pressure will be evaluated.	every 5 min till the end of procedure	Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure
Adverse reactions of hemostatic stuffing after FESS will be evaluated.	24 hour postoperatively	1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate
Pain score will be evaluated.	24 hour postoperatively	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

Trial Locations

Locations (1)

Mohammad Fouad Algyar; 🇪🇬 Kafr Ash Shaykh, Kafr El-Shaikh, Egypt