Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
| Registry | NCT05604599 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: triple, prevention |
| Enrollment | 60 (Actual) |
| Sponsor | Al-Azhar University (Other) |
| Conditions | Functional Endoscopic Sinus Surgery, Premedication, Analgesia |
| Interventions | Intranasal dexmedetomidine, Intravenous dexmedetomidine (Drug) |
| Dates | start 2022-11-10, primary completion 2023-03-05, completion 2023-03-05, first posted 2022-11-03, last updated 2023-03-14 |
| Locations | 1 site in Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Functional Endoscopic Sinus Surgery All trials for Premedication All trials of Intranasal dexmedetomidine All trials of Intravenous dexmedetomidine
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Intranasal dexmedetomidine group | Active comparator | Drug: Intranasal dexmedetomidine | 30 patients will receive 1µg/kg dexmedetomidine diluted in 10ml 0.9% saline intranasally preoperative administered to each naris as drops 45 -60 min before the operation +infusion saline. |
| Intravenous dexmedetomidine group | Active comparator | Drug: Intravenous dexmedetomidine | 30 patients will receive a dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia + intranasal saline. |
Sex: All, ages: 21 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Facualty of Medicine(Damietta), Al Azhar University | Damietta | Egypt |