Enhanced Recovery After Spinal Surgery Protocol Versus Conventional Care in Non Insulin Diabetic Patients:A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Quality of recovery after surgery (QoR40)
研究概览
简要总结
enhanced recovery after spinal surgery protocol (ERAS) versus conventional care in non insulin diabetic patients. Our hypothesis is that non-insulin dependent diabetic patients who will undergo lumbar decompression surgery following ERAS care may have higher quality of recovery after surgery, lower postoperative pain scores, decreased opioid consumption, reduced Length of stay and reduce perioperative stress compared to conventional general anaesthesia.
详细描述
72 patients of American Society of Anaesthesiology (ASA) physical status II or III, of both sexes, aged (30-65) years admitted to department of neurosurgery, Alexandria Main University Hospital and scheduled for elective lumbar decompression surgeries under the effect of general anaesthesia.
All patients will be randomized 1:1 using a sealed envelope method to receive their perioperative care under our ERAS protocol versus conventional care. The envelope will be opened by an observer not involved in the study. Patients will be divided into two equal groups.
Group (E): ERAS group: 36 non-insulin dependent diabetic patients will undergo lumbar decompression surgery following ERAS protocol.
Group (C): Conventional group: 36 non-insulin dependent diabetic patients will undergo lumbar decompression surgery under conventional perioperative care.
During preoperative visit, evaluation of patients will be carried out through proper history taking, clinical examination and routine laboratory investigations including complete blood picture, coagulation profile, blood urea, serum creatinine, serum electrolytes, fasting blood glucose, glycosylated haemoglobin (HBA1C), liver function tests and any other investigation needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
single
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30-65 years, both sexes
- •ASA physical status class II and III
- •2-3 levels elective lumbar surgery.
- •Controlled non- insulin dependent diabetic patients (HbA1C ≤ 7% )
排除标准
- •Cervical and thoracic surgery
- •More than 3 levels surgery.
- •Cognitive impairment.
- •Infection, trauma, neoplasm.
- •Revision surgery.
- •Patients with BMI > 35 kg/m2, renal or cardiac and liver failure.
- •Patients with retinopathy or reduction of visual acuity.
- •Patients with known hypersensitivity or contraindication to medications.
- •Coagulopathy or uncontrolled Diabetes mellitus (DM) .
- •Patients receiving any analgesic medications within 24 h pre-operative or antiplatelet medication within the past 1 week.
- •Patients who had symptoms of nausea and vomiting or received an antiemetic within 24 h of surgery.
- •Random blood glucose more than 250 mg/dl just before shifting the patient from the ward to the operating room.
结局指标
主要结局
Quality of recovery after surgery (QoR40)
时间窗: postoperative day 2
40-item questionnaire that assesses five dimensions of recovery after surgery and anesthesia: comfort, emotions, physical independence, patient support, and pain and has a mean time to completion of 5 min.
次要结局
- mean arterial blood pressure(surgery period)
- Perioperative nalbuphine requirements(24 hours postoperative)
- postoperative hospital stay(postoperative day 5)
- serum markers of stress response: interleukin 6 ( IL-6)(postoperative day 2)
- Number of patients required rescue anti-emetic postoperatively(24 hours postoperative)
- Time to first postoperative analgesic request(24 hours postoperative)
- Blood sugar level(time of admission to PACU)
- serum markers of stress response: C reactive protein ( CRP)(postoperative day 2)
- heart rate(surgery period)
- Postoperative pain score(8 hours postoperative)
- number of participants with Perioperative complications(postoperative day 5)
研究者
sarah mohamed
Assistant lecturer, alexandria university
Alexandria University