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

NCT06081933 | Unknown Phase 4

• 1 other identifier: MKSU-50-9-20
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dexmedetomidine; Functional Endoscopic Sinus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Heart rate will be evaluated

  every 5 min till the end of procedure

• Mean arterial blood pressure will be evaluated.

  every 5 min till the end of procedure

• Pain score will be evaluated.

  24 hour postoperatively

• Adverse reactions of hemostatic stuffing after FESS will be evaluated.

  24 hour postoperatively

Study Arms (2)

intranasal dexmedetomidine

EXPERIMENTAL

Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline

Drug: intranasal dexmedetomidine

intravenous dexmedetomidine

EXPERIMENTAL

patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.

Drug: intravenous dexmedetomidine

Interventions

intranasal dexmedetomidine DRUG

Patients will receive 1.5 micro g/kg intranasal dexmedetomidine diluted with saline + infusion saline

intranasal dexmedetomidine

intravenous dexmedetomidine DRUG

patients will receive 0.1- 0.4 micro g/kg intravenous infusion dexmedetomidine + intranasal saline.

intravenous dexmedetomidine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Mohammad Fouad Algyar

Kafr ash Shaykh, Kafr El-Shaikh, 33516, Egypt

RECRUITING

Study Officials

• Kamal Ebeid, MD

  Lecturer of Otorhinolaryngology, Faculty of medicine, Tanta University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad F Algyar, MD

CONTACT

00201111645345; mohammad.algaiar@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anaesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: October 13, 2023
• Study Start: December 20, 2022
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After one year

Locations

EG (1)