Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Phase 4

Completed

• Conditions: Premedication; Analgesia; Functional Endoscopic Sinus Surgery
• Interventions: Drug: Intranasal dexmedetomidine; Drug: Intravenous dexmedetomidine

• Registration Number: NCT05604599
• Lead Sponsor: Al-Azhar University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-28
• Study First Submitted QC: 2022-11-02
• Study First Posted: 2022-11-03
• Study Start: 2022-11-10
• Status Verified: 2023-03
• Primary Completion: 2023-03-05
• Study Completion: 2023-03-05
• Last Update Submitted: 2023-03-10
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal dexmedetomidine group	Intranasal dexmedetomidine	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.
Intravenous dexmedetomidine group	Intravenous dexmedetomidine	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

Facualty of Medicine(Damietta), Al Azhar University; 🇪🇬 Damietta, Egypt