Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS
NCT ID: NCT05604599
Last Updated: 2023-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2022-11-10
2023-03-05
Brief Summary
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Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Intranasal dexmedetomidine group
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.
Intranasal dexmedetomidine
45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline
Intravenous dexmedetomidine group
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.
Intravenous dexmedetomidine
patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.
Interventions
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Intranasal dexmedetomidine
45 -60 min before the operation, patients will receive dose of dexmedetomidine 1microgram/kg diluted in 10ml 0.9% saline administered to each naris as drops + infusion saline
Intravenous dexmedetomidine
patients will receive loading dose of dexmedetomidine 1 µg/kg diluted in 10ml 0.9% saline infused over 45- 60 min before induction of anesthesia, followed by continuous infusion of (0.4 µ g/kg/h) + intranasal saline.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.
Exclusion Criteria
* 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.
21 Years
70 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Locations
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Facualty of Medicine(Damietta), Al Azhar University
Damietta, , Egypt
Countries
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Other Identifiers
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IRB 00012367-22-011-001
Identifier Type: -
Identifier Source: org_study_id
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