Intranasal vs. IV Dexmedetomidine in Endoscopic Sinus Surgery

NCT05595083 | Unknown

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

Brief Summary

The aim of this study is to compare intranasal dexmedetomidine versus intravenous dexmedetomidine for improving the quality of the operative field in Functional endoscopic sinus surgery (FESS).

Conditions

Functional Endoscopic Sinus Surgery; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Formmer's scores of surgical field quality

  Formmer's scores (a 6-point scale) of surgical field quality will be used to record the amount of bleeding (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)

  Intraoperatively

Secondary Outcomes (4)

• Hemodynamics effects

  at baseline and every 5 min till the end of procedure

• Hemodynamics effects

  at baseline and every 5 min till the end of procedure

• Pain level

  24 hour postoperatively

• Adverse reactions

  24 hour postoperatively

Study Arms (2)

intranasal dexmedetomidine group

EXPERIMENTAL

patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline

Drug: intranasal dexmedetomidine group

intravenous dexmedetomidine group

EXPERIMENTAL

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

Drug: intravouns dexmedetomidine group

Interventions

intranasal dexmedetomidine group DRUG

patients will receive 1.5 ug/kg intranasal dexmedetomidine diluted with saline + infusion saline

intranasal dexmedetomidine group

intravouns dexmedetomidine group DRUG

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

intravenous dexmedetomidine group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years of age
• Both genders
• American Society of Anesthesiologists (ASA) physical status classification I or II
• Undergoing Functional Endoscopic Sinus Surgery.

You may not qualify if:

• Patients with a body mass index \> 30 kg/m\^2
• 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

Tanta, ElGharbiaa, 31511, Egypt

RECRUITING

Central Study Contacts

Mohammad F. Algyar F. Algyar, MD

CONTACT

111645345; mohammad.algaiar@med.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• 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 Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: October 26, 2022
• Study Start: November 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)