Functional Endoscopic Sinus Surgery, Premedication, Analgesia
Conditions
Keywords
Dexmedetomidine, Intranasal, Intravenous
Brief summary
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.
Interventions
DRUGIntranasal 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
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.
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving quality of the operative field. | during surgery (intraoperatively) 2 hours | 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. |
| Amount of atropine consumption | First 24 hours postoperatively | The total amount of atropine consumed will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain score | First 24 hours postoperatively | 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. |
| Hemodynamics(Heart rate (bpm)) | 2 hours | 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. |
| hemostatic stuffing | 24 hours postoperatively | 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). |
| Adverse events | 24 postoperatively | Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia. |
| Hemodynamics(Mean arterial blood pressure mm Hg)) | 2 hours | 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. |
Countries
Egypt
Outcome results
None listed