Intranasal vs. IV Dexmedetomidine in 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: NCT05595083
• Other study ID #: MKSU 50-9-20
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: September 2023
• Source: Kafrelsheikh University
• Contact: Mohammad F. Algyar F. Algyar, MD
• Phone: 111645345
• Email: mohammad.algaiar[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).

Description:

Functional endoscopic sinus surgery (FESS) is a well-established therapeutic option for intractable Cytokine release syndrome (CRS) and other indications. Functional endoscopic sinus surgery (FESS) is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, the risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid [CSF] leakage, and the duration of surgery increase . Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications .

Increased bleeding sometimes causes surgeries to end before the due time. Improvement of intraoperative visibility while reducing bleeding is an important task for anesthesiologists during Functional endoscopic sinus surgery (FESS).

For this purpose, several pharmaceuticals have been used successfully to produce controlled hypotension during general anesthesia, for example inhalational anesthetics, direct vasodilators (sodium nitroprusside and nitroglycerin), beta adrenergic antagonists (propranolol and esmolol), alpha adrenergic agonists (clonidine and dexmedetomidine), calcium channel blockers, prostaglandin E1 (alprostadil) and adenosine and l-receptors agonists (remifentanil) .

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. Potentially desirable effects include decreased requirements for other anesthetics and analgesics. The most common adverse effects associated with Dexmedetomidine include hypotension, bradycardia, and even hypertension.

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 ug/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: October 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients older than 18 years of age

• Both genders

• American Society of Anesthesiologists (ASA) physical status classification I or II

• Undergoing Functional Endoscopic Sinus Surgery.

Exclusion Criteria:

• Patients with a body mass index > 30 kg/m^2

• 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
• Functional Endoscopic Sinus Surgery

Intervention

Drug:
• intranasal dexmedetomidine group
patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline
• intravouns dexmedetomidine group
patients will receive 0.1- 0.4 ug/kg intravenous infusion dexmedetomidine + intranasal saline.

Locations

Country	Name	City	State
Egypt	Mohammad Fouad Algyar	Tanta	ElGharbiaa

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Formmer's scores of surgical field quality	Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding)	Intraoperatively
Secondary	Hemodynamics effects	Heart rate will be recorded	at baseline and every 5 min till the end of procedure
Secondary	Hemodynamics effects	Mean arterial blood pressure will be recorded	at baseline and every 5 min till the end of procedure
Secondary	Pain level	Pain level will be evaluated using numeric rating analogue scale (NRS), which ranges from 0 to 10 points, with 0 indicating no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain, and 7-10 indicating severe pain.	24 hour postoperatively
Secondary	Adverse reactions	Adverse reactions of hemostatic stuffing after Functional endoscopic sinus surgery (FESS) will be evaluated.	24 hour postoperatively