Analgesia Clinical Trial
Official title:
Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
Verified date | March 2023 |
Source | Al-Azhar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery. Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.
Status | Completed |
Enrollment | 60 |
Est. completion date | March 5, 2023 |
Est. primary completion date | March 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 70 Years |
Eligibility | Inclusion Criteria: - Patients older than 21 years of age. - Both genders. - American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus 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. - 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Facualty of Medicine(Damietta), Al Azhar University | Damietta |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improving quality of the operative field. | Quality of intraoperative surgical field during functional endoscopic sinus 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. | during surgery (intraoperatively) 2 hours | |
Primary | Amount of atropine consumption | The total amount of atropine consumed will be recorded | First 24 hours postoperatively | |
Secondary | Hemodynamics(Heart rate (bpm)) | Heart rate (bpm), at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery. | 2 hours | |
Secondary | Hemodynamics(Mean arterial blood pressure mm Hg)) | Mean arterial blood pressure mm Hg) at base line, 5minute, 10 minute , 30 minute, 45 minute, 60 minute after patient received intranasal and after infusion of loading dose of dexmedetomidine , 5, 15, 30, 45, 60 minutes after induction of anesthesia, at end of surgery and 30 minute after recovery. | 2 hours | |
Secondary | Pain score | Pain measured with VAS: (visual analogue scale) will be assessed in post anesthesia care unit, 1, 2, 4, 6, 8, 12, 18, and 24hours postoperative.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). patients are asked to rate their current level of pain by placing a mark on the line. |
First 24 hours postoperatively | |
Secondary | Adverse events | Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia. | 24 postoperatively | |
Secondary | hemostatic stuffing | The degree of adverse reactions of hemostatic stuffing after functional endoscopic sinus surgery will be also evaluated (1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate). | 24 hours postoperatively |
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