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

Kafrelsheikh University

Status and phase: Enrolling; Phase 4

Conditions: Functional Endoscopic Sinus; Dexmedetomidine

Treatments: Drug: intravenous dexmedetomidine; Drug: intranasal dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT06081933

MKSU-50-9-20

Details and patient eligibility

About

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

Full 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

Enrollment: 54 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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54 participants in 2 patient groups

intranasal dexmedetomidine

Experimental group

Description:

Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline

Treatment:

Drug: intranasal dexmedetomidine

intravenous dexmedetomidine

Experimental group

Description:

patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.

Treatment:

Drug: intravenous dexmedetomidine