Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Al-Azhar University

Status and phase: Completed; Phase 4

Conditions: Premedication; Analgesia; Functional Endoscopic Sinus Surgery

Treatments: Drug: Intranasal dexmedetomidine; Drug: Intravenous dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05604599

IRB 00012367-22-011-001

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Intranasal dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Intranasal dexmedetomidine

Intravenous dexmedetomidine group

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous dexmedetomidine