Dexmedetomidine Clinical Trial
Official title:
Nasal Packing Versus Intravenous Dexmedetomidine in Turbinate Surgeries: A Randomized Double-Blinded Trial
Verified date | March 2024 |
Source | Kafrelsheikh University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Comparing of nasal packing DEX and IV DEX for controlling the intraoperative bleeding after turbinate surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | February 27, 2024 |
Est. primary completion date | February 27, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Karelsheikh University Hospital | Kafr Ash Shaykh | Karelsheikh |
Lead Sponsor | Collaborator |
---|---|
Kafrelsheikh University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Amount of intraoperative blood loss | Measuring the volume of suctioned blood in graduated columns, which will contain an anticoagulant to prevent coagulation and clotting and weighing gauze sponges. | Intraoperative up to 6hours | |
Secondary | Pain score | Visual analogue scale (VAS) (0, no discomfort and no pain; 10, a high level of discomfort and maximum pain) | 24 hours postoperative | |
Secondary | Quality of intraoperative surgical field | Quality of intraoperative surgical field during after turbinate surgery will be evaluated by the surgeons by rating the amount of bleeding according to a 6-point scale by Formmer's scores of surgical field quality (0= no bleeding; 1= bleeding, so mild it was not even a surgical nuisance; 2= moderate bleeding, a nuisance but without interference; 3= moderate bleeding that moderately compromised surgical; 4= bleeding, heavy but controllable, that significantly interfered; 5= massive uncontrollable bleeding) | Intraoperative up to 6hours | |
Secondary | Patient's general satisfaction | Patients' satisfaction will be measured immediately postoperative and using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied. | 24 hours postoperative |
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