Effect of Nasal Dexmedetomidine Versus Systemic Infusion Dexmedetomidine in Reducing Intraoperative Opioid Consumption in Nasal Endoscopic Surgeries: A Prospective Randomized Controlled Study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary: Intraoperative fentanyl use.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Both sexes.
- •American Society of Anesthesiology (ASA) physical status I-II.
- •Patients underwent nasal endoscopic surgeries under general anesthesia.
排除标准
- •Patient refusal.
- •Severe complication with the injection of dexmedetomidine as first degree or second-degree atrioventricular block, atrial fibrillation.
- •Hypersensitivity to the drug.
研究组 & 干预措施
Group A: Dexmedetomidine IV infusion (0.5 mcg/kg/h) after induction
干预措施: 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)
Group B: Intranasal dexmedetomidine 1 ml (100 mcg) preoperatively.
干预措施: 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)
结局指标
主要结局
Primary: Intraoperative fentanyl use.
时间窗: 40 minutes
次要结局
未报告次要终点
研究者
Marianne Magdy Youssef
Lecturer of anesthesia ,icu&pain management
Cairo University