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Clinical trial

Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial

ID
Name
MKSU-50-9-20
Description
compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery
Trial arms
Trial start
2022-12-20
Estimated PCD
2023-12-15
Trial end
2023-12-15
Status
Recruiting
Phase
Early phase I
Treatment
intranasal dexmedetomidine
Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline
Arms:
intranasal dexmedetomidine
intravenous dexmedetomidine
patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.
Arms:
intravenous dexmedetomidine
Size
54
Primary endpoint
Improving quality of the operative field
24 hours postoperative
Eligibility criteria
Inclusion Criteria: * Patients underwent Functional Endoscopic Sinus Surgery * American Society of Anesthesiologists (ASA) physical status classification I or II 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 * 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, patients with a history of previous Functional Endoscopic Sinus Surgery
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 54, 'type': 'ESTIMATED'}}
Updated at
2023-10-13

1 organization

1 product

2 indications

Organization
Kafrelsheikh University
Product
Dexmedetomidine
Indication
Dexmedetomidine
Indication
Functional Endoscopic Sinus