The Effect of Intrathecal Bupivacaine Temperature Variation on Prophylaxis of Post-Spinal Shivering in Urologic Patients Undergoing Spinal Anesthesia (A Randomized, Controlled, Double-Blinded Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of Shivering
研究概览
简要总结
The aim of this study is to evaluate the effect of temperature variation of injected intrathecal bupivacaine on prophylaxis of post-spinal shivering in urological patients undergoing spinal anaesthesia.
详细描述
Preoperative:
After obtaining informed consent the day before surgery by an anesthetist who is not involved in the study from the patient. Subjects with contraindications to regional anaesthesia will be excluded. A history will be taken from all patients. Age and American Society Anesthesiologists' (ASA) score will be recorded. Laboratory investigations including complete blood picture, coagulation profile, liver and renal functions will be recorded. General examination will be conducted with examination of the back to exclude infection at the injection site and anatomical deformities.
Intra-operative:
The study consists of three groups: group A, group B and group C
- Group A patients will be injected with 15 mg heavy bupivacaine 0.5% (equals to a volume of 3 ml) intrathecally plus 25 µg fentanyl that is adjusted to temperature of (4°C) by being stored in a pharmaceutical refrigerator by adjusting its thermostat to be on 4°C and consists of 18 patient.
- Group B patients will be injected with 15 mg heavy bubivacaine 0.5% (equals to a volume of 3 ml) intrathecally plus 25 µg fentanyl that is stored at room temperature of (24°C) by adjusting the temperature settings of the air conditioning and consists of 18 patient.
- Group C patients will be injected with 15 mg heavy bupivacaine 0.5% (equals to a volume of 3 ml) intrathecally plus 25 µg fentanyl that is adjusted to temperature of (37 °C) by using a fluid warming cabinet adjusted to be on 37 °C and consists of 18 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adult patients scheduled for urological procedures under spinal anaesthesia.
- •Patient age ranges from 18 to 60 years.
- •American Society of Anesthesiologists (ASA) physical status class I or II.
排除标准
- •1. Patient's refusal of regional block.
- •Patients with neurological disorders, increased intracranial pressure, convulsive disorders, autonomic neuropathies, psychological disorders, or those lacking cooperation.
- •3. Patients with anatomical abnormalities, skin lesions, wounds, or infection at the site of injection, or general infection.
- •4. Patients with bleeding disorders defined as (INR>1.4) and/or (platelet count < 100,000/µL).
- •5. Patients with known hypersensitivity to any of the study drugs.
- •Patients with renal impairment.
- •Patients with hepatic disease e.g. severe liver cell failure, or hepatic malignancy, or hepatic enlargement.
- •8. Patients with failed, or partial spinal block.
研究组 & 干预措施
Group B (Room temp group) patients given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (24°C) temp
干预措施: temperature (Procedure)
Group C (Warm group) patients given15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (37 °C) temp
干预措施: temperature (Procedure)
Group A (cold group)patients will be given 15 mg Bupivacaine 0.5% plus Fentanyl 25 ug at (4°C) temp
干预措施: temperature (Procedure)
结局指标
主要结局
Incidence of Shivering
时间窗: starting from the time of the spinal injection (T0) till the discharge from the PACU
the incidence of grade 3 or 4 shivering which will be assessed at 10min intervals starting from the time of spinal block (T0) till the discharge from PACU. and it will be graded according to Wrench scale for shivering. Grade 0: No Shivering. Grade 1: One or more of the following: Piloerection, peripheral vasoconstriction, peripheral cyanosis, but without visible muscle activity Grade 2: Visible muscle activity confined to one muscle group Grade 3: Visible muscle activity in more than 1 muscle group Grade 4: Gross muscle activity involving the whole body.
次要结局
未报告次要终点
研究者
Emad Mohamed Ahmed Abdelhafez
Lecturer of Anesthesia, Critical Care and Pain Management
Kasr El Aini Hospital