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

NCT07012213 | Not Yet Recruiting Early Phase 1

• 1 other identifier: Ms-405-2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Functional Endoscopic Sinus Surgery (FESS)

Outcome Measures

Primary Outcomes (1)

• Primary: Intraoperative fentanyl use.

  40 minutes

Study Arms (2)

Group A: Dexmedetomidine IV infusion (0.5 mcg/kg/h) after induction

ACTIVE COMPARATOR

Drug: 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.

Group B: Intranasal dexmedetomidine 1 ml (100 mcg) preoperatively.

ACTIVE COMPARATOR

Drug: 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.

Interventions

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. DRUG

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.

Group A: Dexmedetomidine IV infusion (0.5 mcg/kg/h) after induction; Group B: Intranasal dexmedetomidine 1 ml (100 mcg) preoperatively.

Eligibility Criteria

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

You may qualify if:

• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-II.
• Patients underwent nasal endoscopic surgeries under general anesthesia.

You may not qualify if:

• Severe complication with the injection of dexmedetomidine as first degree or second-degree atrioventricular block, atrial fibrillation.
• Hypersensitivity to the drug.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasralaini medical school

Cairo, Giza Governorate, 12913, Egypt

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia ,icu&pain management

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 10, 2025
• Study Start: October 15, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 30, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)