Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS (NCT05604599) | Clinical Trial Compass
CompletedPhase 4
Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS
Egypt60 participantsStarted 2022-11-10
Plain-language summary
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.
Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients older than 21 years of age.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.
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.
* 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.
* Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
* Patients with a history of previous functional endoscopic sinus surgery.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improving quality of the operative field.
Timeframe: during surgery (intraoperatively) 2 hours