Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries

NCT ID: NCT05911776

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-02-27

Brief Summary

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

Detailed 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.

Conditions

Nasal Packing; Dexmedetomidine; Turbinate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group NP (nasal packing Dexmedetomidine)

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

Group Type: ACTIVE_COMPARATOR

Nasal packing Dexmedetomidine

Intervention Type: DRUG

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

Group IV (Intravenous Dexmedetomidine)

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.

Group Type: ACTIVE_COMPARATOR

Intravenous Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Nasal packing Dexmedetomidine

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

Intervention Type: DRUG

Intravenous Dexmedetomidine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Gamal Hendawy Shams

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine Faculty of Medicine Kafr-El Sheikh University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Karelsheikh University Hospital

Kafr ash Shaykh, Karelsheikh, Egypt

Countries

Egypt

Other Identifiers

KFSIRB200-3

Identifier Type: -

Identifier Source: org_study_id