Clinical trial

Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial

NCT05911776

Name

KFSIRB200-3

Description

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

Trial arms

Trial start

2023-06-30

Estimated PCD

2024-02-27

Trial end

2024-02-27

Status

Completed

Phase

Early phase I

Treatment

Nasal packing Dexmedetomidine

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

Arms:

Group NP (nasal packing Dexmedetomidine)

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.

Arms:

Group IV (Intravenous Dexmedetomidine)

Size

Primary endpoint

Amount of intraoperative blood loss

Intraoperative up to 6hours

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2024-03-12

1 organization

1 product

3 indications

Organization

Kafrelsheikh University

Product

Indication

Indication

Indication