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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081933
• Other study ID #: MKSU-50-9-20
• Status: Recruiting
• Phase: Phase 4
• Start date: December 20, 2022
• Est. completion date: December 15, 2023

Study information

• Verified date: March 2023
• Source: Kafrelsheikh University
• Contact: Mohammad F Algyar, MD
• Phone: 00201111645345
• Email: mohammad.algaiar[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 15, 2023
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dexmedetomidine

Intervention

Drug:
• intranasal dexmedetomidine
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.

Locations

Country	Name	City	State
Egypt	Mohammad Fouad Algyar	Kafr Ash Shaykh	Kafr El-Shaikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving quality of the operative field	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.	24 hours postoperative
Secondary	Heart rate will be evaluated	Heart rate will be recorded at baseline and every 5 min till the end of procedure	every 5 min till the end of procedure
Secondary	Mean arterial blood pressure will be evaluated.	Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure	every 5 min till the end of procedure
Secondary	Pain score will be evaluated.	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	24 hour postoperatively
Secondary	Adverse reactions of hemostatic stuffing after FESS will be evaluated.	1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate	24 hour postoperatively