A comparative study of the effects of dexmedetomidine and remifentanil on perioperative hemodynamics and recovery profile in patients undergoing functional endoscopic sinus surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- To compare perioperative hemodynamic alterations, including pressure,
研究概览
简要总结
A prospective randomized comparative clinical trial was conducted over 12 months at IMS and SUM Hospital Bhubaneswar by the Department of Anesthesiology in collaboration with the Department of ENT for patients undergoing Functional Endoscopic Sinus Surgery FESS. A total of 88 patients aged 18 to 60 years classified as ASA I and II were randomly assigned into two groups of 44 each using a computer-generated randomization table.
Group DEM received Dexmedetomidine 1 mcg per kg as a loading dose over 10 minutes followed by a saline bolus of 5 mL before induction and a maintenance infusion of 0.5 mcg per kg per min. Group REM received a saline placebo over 10 minutes Remifentanil 1 mcg per kg as a loading dose before induction and a maintenance infusion of 0.5 mcg per kg per min.
Preoperative assessment included history physical examination airway assessment ASA grading and baseline vital signs. Patients were preoxygenated with 100 percent oxygen at 10 L per min for 3 minutes and IV access was secured using an 18G cannula with fluid preload of Ringers Lactate 10 mL per kg.
Premedication included IV Glycopyrrolate 0.2 mg Midazolam 1 mg Pantoprazole 40 mg and Ondansetron 4 mg. Induction was achieved with Propofol 1.5 to 2 mg per kg and Vecuronium 0.1 mg per kg followed by endotracheal intubation.
Anesthesia was maintained with Isoflurane oxygen air and additional Vecuronium as required. End tidal CO2 was maintained between 35 and 45 mmHg. Hemodynamic parameters including BP HR SpO2 and ECG were recorded at baseline every 5 minutes for the first 15 minutes and then every 15 minutes thereafter.
At the end of surgery study drugs were stopped and reversal was achieved using Sugammadex 2 mg per kg followed by extubation upon adequate recovery.
Postoperative recovery was assessed every 10 minutes for 60 minutes focusing on RASS VNRS and adverse events. In the PACU RASS was monitored every 15 minutes during the first hour then every 30 minutes until discharge. A Modified Aldrete Score of 9 or higher was required for PACU discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
入选标准
- •Patients scheduled for elective Functional Endoscopic Sinus Surgery (FESS).
- •Gender: Male and female participants.
- •Age Range: 18 to 60 years.
- •Body Mass Index (BMI): Less than 30 kilograms per square meter (kg/m²).
- •ASA Physical Status Classification: Grade I and II according to the American Society of Anesthesiologists (ASA) guidelines.
排除标准
- •Patients who are not willing to participate Patients under ASA 3 and ASA 4 Hemodynamic instability defined as intraoperative uncontrolled blood pressure more than 180 by 100 mmHg or less than 90 by 50 mmHg despite appropriate management BMI greater than or equal to 30 kg per m2 Pregnant or lactating patients Patients with conditions impairing effective communication and assessment.
结局指标
主要结局
To compare perioperative hemodynamic alterations, including pressure,
时间窗: To compare perioperative hemodynamic alterations, including pressure, | -heart rate, | - oxygen saturation(spo2) | 2)To evaluate postoperative recovery using the Modified Aldrete Score.
-heart rate,
时间窗: To compare perioperative hemodynamic alterations, including pressure, | -heart rate, | - oxygen saturation(spo2) | 2)To evaluate postoperative recovery using the Modified Aldrete Score.
- oxygen saturation(spo2)
时间窗: To compare perioperative hemodynamic alterations, including pressure, | -heart rate, | - oxygen saturation(spo2) | 2)To evaluate postoperative recovery using the Modified Aldrete Score.
2)To evaluate postoperative recovery using the Modified Aldrete Score.
时间窗: To compare perioperative hemodynamic alterations, including pressure, | -heart rate, | - oxygen saturation(spo2) | 2)To evaluate postoperative recovery using the Modified Aldrete Score.
次要结局
- Postoperative Pain – Measured using the Visual Analog Scale (VAS)(Sedation Levels – Measured using the Richmond Agitation Sedation Scale (RASS))
研究者
Medampudi Bhargavii
IMS and SUM Hospital