Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

Kafrelsheikh University

Status and phase: Completed; Phase 4

Conditions: Dexmedetomidine; Turbinate; Nasal Packing

Treatments: Drug: Intravenous Dexmedetomidine; Drug: Nasal packing Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05911776

KFSIRB200-3

Details and patient eligibility

About

Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.

Full description

Dexmedetomidine (DEX) is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes DEX primarily sedative and anxiolytic. The elimination half-life of DEX (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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 65 years
• Both sexes
• American Society of Anesthesiologists (ASA) physical status classification I or II.
• Undergo turbinate 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 or any known genetic predisposition.
• History of any kind of drug allergy,
• Drug abuse.
• 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 turbinate surgery.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group NP (nasal packing Dexmedetomidine)

Active Comparator group

Description:

Patients will receive nasal packing Dexmedetomidine (1.5 μg/kg intranasal dexmedetomidine diluted with saline) and Intravenous infusion saline.

Treatment:

Drug: Nasal packing Dexmedetomidine

Group IV (Intravenous Dexmedetomidine)

Active Comparator group

Description:

Patients will receive 0.5 μg/kg bolus over 10 min then 0.1- 0.4 μg/kg IV infusion Dexmedetomidine and nasal packing with saline.

Treatment:

Drug: Intravenous Dexmedetomidine