Comparing intranasal and IV dexmedetomidine for sinus surgery
Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial
NA · Kafrelsheikh University · NCT05595083
This study is testing whether giving dexmedetomidine through the nose or through an IV helps reduce bleeding and improve conditions during sinus surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 54 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Kafrelsheikh University (other) |
| Locations | 1 site (Tanta, ElGharbiaa) |
| Trial ID | NCT05595083 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of intranasal dexmedetomidine versus intravenous dexmedetomidine in enhancing the quality of the operative field during Functional Endoscopic Sinus Surgery (FESS). FESS is a minimally invasive procedure often performed under controlled hypotensive anesthesia, where intraoperative bleeding can compromise visibility and increase complication risks. By evaluating these two administration routes of dexmedetomidine, the study seeks to determine which method better reduces bleeding and improves surgical conditions. The findings could provide valuable insights for anesthesiologists in optimizing patient outcomes during sinus surgeries.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old, of any gender, classified as ASA physical status I or II, and scheduled for Functional Endoscopic Sinus Surgery.
Not a fit: Patients with a body mass index over 30 kg/m², contraindications to dexmedetomidine, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing sinus surgery.
How similar studies have performed: While the use of dexmedetomidine in anesthesia is established, this specific comparison of intranasal versus intravenous administration in the context of FESS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tanta, ElGharbiaa
- Mohammad Fouad Algyar — Tanta, ElGharbiaa, Egypt (RECRUITING)
Study contacts
- Study coordinator: Mohammad F. Algyar F. Algyar, MD
- Email: mohammad.algaiar@med.kfs.edu.eg
- Phone: 111645345
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Endoscopic Sinus Surgery, Dexmedetomidine