Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial
Overview
- Phase
- Phase 4
- Intervention
- Intranasal dexmedetomidine
- Conditions
- Functional Endoscopic Sinus Surgery
- Sponsor
- Al-Azhar University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improving quality of the operative field.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Intranasal dexmedetomidine
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.
Intervention: Intravenous dexmedetomidine
Outcomes
Primary Outcomes
Improving quality of the operative field.
Time Frame: 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
Time Frame: First 24 hours postoperatively
The total amount of atropine consumed will be recorded
Secondary Outcomes
- Hemodynamics(Heart rate (bpm))(2 hours)
- Hemodynamics(Mean arterial blood pressure mm Hg))(2 hours)
- Pain score(First 24 hours postoperatively)
- hemostatic stuffing(24 hours postoperatively)
- Adverse events(24 postoperatively)