NCT07012213

Nasal Dexmedetomidine Versus Systemic Infusion Dexmedetomidine in Reducing Intraoperative Opioid Consumption in Nasal Endoscopic Surgeries

Not yet recruiting EARLY_PHASE1 Last updated 4 July 2025

What this trial tests

EARLY_PHASE1 trial testing Patients in group A received .5 g/kg/h dexmedetomidine infusion after general anesthesia, in group B received 1 ml (100 mic) dexmedetomidine intranasal spray before induction. in Functional Endoscopic Sinus Surgery (FESS) in 50 participants. Not yet recruiting.

Timeline

15 October 2025

Primary endpoint
15 November 2025

30 December 2025

Quick facts

Lead sponsor	Cairo University
Phase	EARLY_PHASE1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	15 October 2025
Primary completion	15 November 2025
Estimated completion	30 December 2025
Sites	1 location across Egypt

Drugs / interventions tested

• Patients in group A received .5 g/kg/h dexmedetomidine infusion after general anesthesia, in group B received 1 ml (100 mic) dexmedetomidine intranasal spray before induction.

Conditions studied

• Functional Endoscopic Sinus Surgery (FESS) — all drugs for Functional Endoscopic Sinus Surgery (FESS) →

Sponsor

Cairo University

Who can join

18 and older, any sex, with Functional Endoscopic Sinus Surgery (FESS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Optimizing intraoperative hemodynamics and minimizing opioid use are crucial in nasal endoscopic surgeries.

Objective: To compare the efficacy of intranasal dexmedetomidine spray and intravenous dexmedetomidine infusion in reducing intraoperative opioid requirements and improving perioperative outcomes.

Methods: A prospective randomized controlled study was conducted on 50 patients undergoing nasal endoscopic surgeries. Patients will be randomized into two groups: Group A received IV dexmedetomidine infusion; Group B received intranasal dexmedetomidine. Intraoperative fentanyl use, postoperative morphine consumption, hemodynamic parameters, and pain scores will be evaluated.

Measurements:

All the following data will be collected:

* Demographic data: age, sex, weight, height, BMI, ASA class, indication and duration of surgery.
* Hemodynamic Parameters: HR, BP, SpO2, and MAP will be recorded preoperative, and every 10 min till the end of surgery.
* Quality of surgical field through endoscopic surgical field grading system Primary outcome is Reducing opioid consumption intraoperatively to give the best surgical field control and hemodynamic control. Secondary outcomes are pain score postoperative, postoperative analgesics, and surgical field satisfaction.

Statistical analysis Statistical analysis will be done by SPSS v26 (IBM Inc., Chicago, IL, USA). Shapiro-Wilks test and histograms will be used to evaluate the normality of the distribution of data. Quantitative parametric variables will be presented as mean and standard deviation (SD) and compare between the two groups utilizing unpaired Student's T- test. Quantitative non-parametric data will be presented as median and interquartile range (IQR) and will be analyzed by Mann Whitney-test. Qualitative variables will be presented as frequency and percentage (%) and will be analyzed utilizing the Chi-square test or Fisher's exact test when appropriate. A two tailed P value \< 0.05 is considered statistically significant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.