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NCT Number: NCT07012213

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Kasralaini medical school

Cairo, Giza Governorate, 12913, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Age ≥ 18 years.

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

Exclusion criteria

• Patient refusal.

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

Treatment and study plan

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.

Primary outcomes

  1. Primary: Intraoperative fentanyl use.

    Time frame: 40 minutes

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Nasal Dexmedetomidine Versus Systemic Infusion Dexmedetomidine in Reducing Intraoperative Opioid Consumption in Nasal Endoscopic Surgeries: A Prospective Randomized Controlled Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 10, 2025
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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