Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of Endoscopic Sinus Surgery

Intranasal Dexmedetomidine Versus Intravenous Dexmedetomidine for Improving Quality of the Operative Field in Functional Endoscopic Sinus Surgery: A Randomized Triple-Blind Trial

compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving quality of the operative field in Functional endoscopic sinus surgery

Study Overview

• Status: Recruiting
• Conditions: Dexmedetomidine; Functional Endoscopic Sinus
• Intervention / Treatment: Drug: intranasal dexmedetomidine; Drug: intravenous dexmedetomidine

Detailed Description

Functional endoscopic sinus surgery is a well-established therapeutic option for intractable CRS and other indications. Functional endoscopic sinus surgery is a minimally invasive procedure and is commonly performed under controlled hypotensive anesthesia. In case of major bleeding, risk of complications such as meningitis, blindness, intracranial injury, cerebrospinal fluid leakage and the duration of surgery increase. Intraoperative bleeding is the most common factor that diminishes visibility, resulting in an increased incidence of complications.

Dexmedetomidine is a highly selective α2 adreno-receptor agonist with higher affinity to a2 adreno-receptor than clonidine, and this makes dexmedetomidine primarily sedative and anxiolytic.The elimination half-life of dexmedetomidine (t1/2b) is 2 h and the redistribution half-life (t1/2a) is 6 min, and this short half-life makes it an ideal drug for intravenous titration.

Intranasal Dexmedetomidine is convenient, effective, and noninvasive and also has useful analgesic and sedative effects in surgical procedures. Cheung's research has shown that intranasal Dexmedetomidine 1 and 1.5 micro/kg in surgical procedures produced significant sedation and less postoperative pain. Several previous research were determined the effect of intranasal dexmedetomidine in several clinical evaluations

• Study Type: Interventional
• Enrollment (Estimated): 54
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Mohammad F Algyar, MD; Phone Number: 047 00201111645345; Email: mohammad.algaiar@med.kfs.edu.eg

Study Locations

• Egypt
  • Kafr El-Shaikh
    • Kafr Ash Shaykh, Kafr El-Shaikh, Egypt, 33516
      • Recruiting
      • Mohammad Fouad Algyar
      • Contact: Mohammad F Algyar, MD; Phone Number: 047 00201111645345; Email: mohammad.algaiar@med.kfs.edu.eg
      • Principal Investigator: Kamal Ebeid, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients underwent Functional Endoscopic Sinus Surgery
• American Society of Anesthesiologists (ASA) physical status classification I or II

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 or 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, patients with a history of previous Functional Endoscopic Sinus Surgery

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intranasal dexmedetomidine; Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline	Drug: intranasal dexmedetomidine; Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline
Experimental: intravenous dexmedetomidine; patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.	Drug: intravenous dexmedetomidine; patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improving quality of the operative field	Patients' satisfaction will be measured immediately postoperative and after 24 hours using a five-point Likert scale consisting of "very dissatisfied," "dissatisfied," "unsure," "satisfied," and "very satisfied.	24 hours postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate will be evaluated	Heart rate will be recorded at baseline and every 5 min till the end of procedure	every 5 min till the end of procedure
Mean arterial blood pressure will be evaluated.	Mean arterial blood pressure will be recorded at baseline and every 5 min till the end of procedure	every 5 min till the end of procedure
Pain score will be evaluated.	Pain score will be evaluated measured with Numerical rating scale The numerical scale is most commonly 0 to 10, with 0 being "no pain" and 10 being "the worst pain imaginable	24 hour postoperatively
Adverse reactions of hemostatic stuffing after FESS will be evaluated.	1=no swelling, can tolerate; 2= swelling, can barely tolerate; 3= swelling, cannot tolerate	24 hour postoperatively

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Principal Investigator: Kamal Ebeid, MD, Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2022
• Primary Completion (Estimated): December 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: October 7, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 7, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• 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; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: MKSU-50-9-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: After one year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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