Different Modalities of Analgesia in Open Heart Surgeries in Mansoura University: Randomized Prospective Comparative Study
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain score at rest assessed using the visual analogue scale.
研究概览
简要总结
Cardiac surgery is associated with post-operative pain which is one of the major problems and remains one of the most controversial issues. Inadequate pain control after cardiac surgery increases the incidence of development of many complications. Intravenous opioids are commonly used for postoperative analgesia either on demand "physician or nurse-controlled" or patient -controlled.
Multimodal opioid sparing analgesia has become frequently used, These techniques can be achieved with Dexmedetomidine, low-dose ketamine and magnesium.
The study hypotheses that control of perioperative quality of pain with opioid sparing medications may improve analgesia and patient outcome.
详细描述
Pain after cardiac surgery is triggered by numerous factors including skin incision, sternotomy, sternal and rib retraction, internal mammary artery and saphenous vein harvesting, surgical manipulation of pleura, placement of chest tubes and tissue trauma during surgery.Median sternotomy significantly reduces postoperative pulmonary function; however, it is the most commonly used approach because it facilitates exposure of the surgical field.
Pain prevents early mobilization, reduction in pulmonary function and accumulation of bronchial secretions resulting in atelectasis, pulmonary infections, hypoxia and increase duration of ICU stay.Prolonged ICU stay is associated with greater risk of respiratory and renal dysfunction, and increases morbidity and mortality.
Optimal post-operative pain management allows early weaning from mechanical ventilation and extubation, early mobilization, facilitate beginning of chest physiotherapy, shortens the length of ICU stay and hospitalization, medical costs and decreases incidence of post-operative complications.
Opioid infusions and patient-controlled analgesia (PCA) remain the principal and most commonly used for immediate postoperative analgesia after cardiac surgery in Intensive Care Units.
Multimodal opioid sparing analgesia has become frequently used. They are used for the opioids sparing effect and for achievement of a more efficient pain management via both central and peripheral anti-nociceptive mechanisms.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The study subjects will be blinded to the allocated groups. The outcome assessor (the investigator who will assess the primary and secondary outcomes) will be blinded to the allocated groups.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients of both gender,
- •Aged above 18 years
- •American Society of Anesthesiologists (ASA) physical status II & III,
- •Body mass index less than 40 kg/m2
- •Scheduled for any cardiac procedure with median sternotomy that require cardiopulmonary bypass at Cardiothoracic Surgical Department, Mansoura University Hospitals.
排除标准
- •Patients with pulmonary dysfunction or chronic obstructive pulmonary diseases
- •Acute or unstable angina
- •Previous cardio-thoracic surgery
- •Emergency surgery
- •Left ventricular ejection fraction less than 40%
- •Dysrhythmia or pacemaker
- •Major hepatic or renal dysfunction
- •Need for re-exploration, uncontrolled diabetes (HbA1c > 8.5)
- •Neurological deficit
- •Hyper-magnesemia
研究组 & 干预措施
High Opioid Group
-The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of mean blood pressure >20% of baseline).
干预措施: Fentanyl (Drug)
Low Opioid Group
The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required).
干预措施: Fentanyl, Propofol (Drug)
Non-Opioid Group
The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
干预措施: Dexmedetomidine, Ketamine, Magnesium sulfate (Drug)
结局指标
主要结局
Pain score at rest assessed using the visual analogue scale.
时间窗: 30 minutes after tracheal extubation
visual analogue scale is a straight horizontal line of fixed length, usually 100 mm. orientated from the left (worst) to the right (best) (where 0 is no pain and 100 is the worst pain) lower score means better outcome
次要结局
- Doses of Inotropic required(from start to the end of surgery)
- Time to tracheal extubation(2 hours to 6 hours)
- Time to either bowel movement or flatus(within 24 hours)
- Diastolic blood pressure(every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative)
- Total opioid consumption(24 hours post operative)
- Pain score at rest assessed using the visual analogue scale.(2, 6, 12, and 24 hours after tracheal extubation)
- Heart rate(every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative)
- Sedation level assessed using Ramsay sedation score(30 minutes, 2, 6, 12, and 24 hours after tracheal extubation)
- Systolic blood pressure(every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative)
- Number of participants with post-operative nausea and vomiting (PONV)(within 24 hours)
- Duration of ICU stay(2 to 5 days)
- Mean arterial blood pressure(every 15 minutes in the first hour then every 30 minutes intraoperative and then 1 hour post-operative)
- Doses of atropine required(from start to the end of surgery)
- Doses of vasopressors required(from start to the end of surgery)
研究者
Ahmed Gamal Morsy
Principle investigator
Mansoura University