Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Intranasal Premedication With Dexmedetomidine Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia During Functional Endoscopic Sinus Surgery in Adults: A Randomized Triple-Blind Trial

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Functional Endoscopic Sinus Surgery; Premedication
• Intervention / Treatment: Drug: Intranasal dexmedetomidine; Drug: Intravenous dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Damietta, Egypt, 34711
    • Facualty of Medicine(Damietta), Al Azhar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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; Other Names: Propofol 2 mg/kg; fentanyl 1 µg/kg; Cis-atracurium 0.15mg / kg; Isoflurane 1-1.5% in 50% oxygen
Active Comparator: 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.	Drug: 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.; Other Names: Propofol 2 mg/kg,, fentanyl 1 µg/kg , Cis-atracurium 0.15mg / kg and Isoflurane 1-1.5% in 50% oxygen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Amount of atropine consumption	The total amount of atropine consumed will be recorded	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Adverse events	Adverse events will be recorded such as nausea, vomiting, hypotension and bradycardia.	24 postoperatively
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

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Actual): March 5, 2023
• Study Completion (Actual): March 5, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 10, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Intranasal; Intravenous
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Inhalation; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Dexmedetomidine; Isoflurane; Cisatracurium; Atracurium
• Other Study ID Numbers: IRB 00012367-22-011-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: data can be shared with a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No