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

NCT ID: NCT06081933

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-20
• Study Completion Date: 2023-12-15

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

Conditions

Dexmedetomidine; Functional Endoscopic Sinus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

intranasal dexmedetomidine

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

Group Type: EXPERIMENTAL

intranasal dexmedetomidine

Intervention Type: DRUG

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

intravenous dexmedetomidine

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

Group Type: EXPERIMENTAL

intravenous dexmedetomidine

Intervention Type: DRUG

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

Interventions

intranasal dexmedetomidine

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

Intervention Type: DRUG

intravenous dexmedetomidine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Fouad Algyar

Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Ebeid, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt

Locations

Mohammad Fouad Algyar

Kafr ash Shaykh, Kafr El-Shaikh, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohammad F Algyar, MD

Role: CONTACT

mohammad.algaiar@med.kfs.edu.eg

00201111645345 ext. 047

Facility Contacts

Mohammad F Algyar, MD

Role: primary

mohammad.algaiar@med.kfs.edu.eg

00201111645345 ext. 047

Other Identifiers

MKSU-50-9-20

Identifier Type: -

Identifier Source: org_study_id