Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05604599
• Other study ID #: IRB 00012367-22-011-001
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2022
• Est. completion date: March 5, 2023

Study information

• Verified date: March 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Analgesia
• Functional Endoscopic Sinus Surgery
• Premedication

Intervention

Drug:
• Intranasal 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
• Intravenous dexmedetomidine
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.

Locations

Country	Name	City	State
Egypt	Facualty of Medicine(Damietta), Al Azhar University	Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

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