A Comparison Between Dexmedetomidine and Fentanyl as Adjuvants to Thoracic Epidural in Patients Undergoing Thoracotomy Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
研究概览
简要总结
To find out if there is a benefit from adding dexmedetomidine to epidural bupivacaine as regards:
- Intra and postoperative opioid consumption
- Pain score (numerical rating scale)
- Hemodynamic stability,
- Patient satisfaction.
详细描述
Following approval from Research Committee of Anesthesia Department and the Ethics Committee of the Faculty of Medicine, Cairo University, 50 patients will be included in the study (25 patients per group). After obtaining written informed consents, all patients will be subjected to systematic preoperative assessment including history taking, physical examination, and review of the results of routine investigations. Upon arrival to the preparation room, a 20G IV cannula will be inserted into a peripheral vein and midazolam 2-3 mg will be administered unless contraindicated. A 20G arterial catheter will be inserted into the radial artery of the dependent (non-operative) side, after local infiltration with lidocaine 2%. Patients will be transferred to the operating room where routine monitoring is applied, including electrocardiography (ECG), invasive Blood Pressure (IBP) and pulse oximetry are attached. Baseline heart rate, blood pressure, oxygen saturation and respiratory rate will be recorded.
A thoracic epidural catheter will be inserted at the T6- T7 intervertebral space, with the patient in the sitting position with standard aseptic precautions using an 18-G Touhy needle via a midline or paramedian approach with a loss of resistance method. A test dose of 3 ml of 2% lignocaine with adrenaline 5 µ/ml will be administered.
For thoracic surgery the sensory dermatome blockade needs to cover the incision and intercostal drains and may extend from T4 to T8.
The epidural drug will be administered according to the group allocation over a period of 10 minutes as follows:
Group A:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Patients will be randomized using a computer-generated list of random numbers, which will be sealed in closed envelopes. Patients will be randomly allocated to one of two groups; Group I will receive dexmedetomidine, while Group II (R) will receive fentanyl. An anesthesiologist who is not involved in the data collection team will perform all thoracic epidural infusion. Intra- and postoperative data will be collected by an anesthesiologist or intensivist who is blinded to the study protocol. So, both the patients and data collector were blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 60 years old
- •ASA physical status I-II-III
- •Good mental function.
- •Patient scheduled for thoracic surgery with posterolateral thoracotomy.
- •BMI of patient (18 - 30).
排除标准
- •Age less than 18 or more than 60 years old
- •Any contraindications to epidural injection (patient refusal, local infection at the site of injection, coagulopathy, patients on anticoagulant or antiplatelet drugs, known allergy to local anesthetics, significant spine deformity)
- •Inability to provide informed consent or pain score
结局指标
主要结局
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
时间窗: 24 hours
Dexmedetomidine compared to fentanyl as adjvant for thoracic epidural for post operative analgesia
次要结局
- mean blood pressure n millimetre mercury(Intraoperative)
- heart rate (beat/ minute)(Intraoperative)
- Pain Score According to Numerical Rating Scale (NRS)(24 Hours)
- Patient Satisfaction with Epidural Infusion(24 hours)
- Systolic arterial blood pressure in millimetre mercury(Intraoperative)
- Diastolic arterial blood pressure in millimetre mercury(Intraoperative)
- First request of analgesia postoperative(24 Hours post operative)
- Incidence of side effects(24 hours)
研究者
mohamed gamal solimn
director
Cairo University