Influence Of Low Dose Intrathecal Naloxone On Bupivacaine - Fentanyl Spinal Anaesthesia For Lower Limb Orthopedic Surgery In Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- incidence of fentanyl - induced pruritus
研究概览
简要总结
Fentanyl is a safer alternative than morphine in the management of postoperative pain in elderly. However, pruritus, nausea and vomiting are unwanted side effects of intrathecal fentanyl administration, that can decrease patient satisfaction with anaesthesia, delay post anaesthesia care unit ( PACU ) discharge, and increase costs.
The incidence of pruritus with neuraxial fentanyl is high. The incidence of pruritus in non-obstetric surgery patients after intrathecal fentanyl ranges from 53% to 79%.
Naloxone hydrochloride is a pure opioid competitive antagonist. Small doses of naloxone may reduce Fentanyl-associated adverse effects, such as pruritus, nausea and vomiting without affecting analgesia.
详细描述
The aim of this study is to evaluate the effect of adding low dose intathecal naloxone to bupivacaine - fentanyl spinal anesthesia in elderly patients scheduled for unilateral lower limb orthopedic surgeries on opioid induced side effects namely pruritus, postoperative analgesia and the incidence of postoperative cognitive dysfunction (POCD) in elderly.
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) will be used for assessment of intrathecal fentanyl induced side effects including pruritus, nausea, vomiting and shivering.
Mini Mental State Examination ( MMSE ) test will be applied to all patients pre- and post- operative to assess the incidence and the degree of POCD.
An 11 points Verbal Numerical Rating Scale VNRS for pain assessment will be also applied to all patients postoperatively to assess the effect on postoperative analgesia.
- Cannulation: Peripheral cannulae ( size 20 gauge or 18 gauge ) will be inserted to all patients . Ringer's acetate warmed up to 37°C will be infused slowly at rate of 7ml/kg, 30 min before induction of spinal anaesthesia. A single intravenous ( I.V. ) dose of prophylactic antibiotic after a negative sensitivity test will be given to all patients 15-30 min. before operation.
- Induction: Patient will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% ( 2.5 mL ) plus 25 µg Fentanyl ( 0.5 mL ) and 20 µg Naloxone ( prepared in 0.5 mL normal saline ) added in the same syringe in a total volume of 3.5 mL..
- Spinal anaesthesia will be conducted while the patients are in the sitting position and under complete aseptic conditions; a lumber puncture at L3-4 or L4-5 interspaces will be performed with a 25- gauge Quincke spinal needle after infiltrating the skin with 2 ml of lidocaine 2%. After a successful dural puncture and ensuring free flow of cerebrospinal fluid, injectates will be injected slowly over 20 seconds without barbotage or aspiration according to group of the patient. Immediately, patients will be turned into the supine position. Oxygen 2-3 L/min will be applied to all patients via nasal prongs.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 60y of either gender.
- •ASA physical status III or below.
- •Patients scheduled for elective unilateral lower limb orthopedic surgery.
排除标准
- •Morbid obese patients.
- •Severe or uncompensated cardiovascular, renal, hepatic or endocrinal diseases.
- •Allergy to one of the agents used.
- •Severely altered consciousness level.
- •Coagulopathy
- •Increased intracranial pressure
- •Neuromuscular diseases
- •Severe spinal deformity
- •Patients on opioid analgesics or opioid abuse
- •Multi traumatized patients
- •Patients with preoperative Mini Mental State Examination ( MMSE ) scoring < 24
研究组 & 干预措施
Bupivacaine-Fentanyl Spinal Anaesthesia
干预措施: Bupivacaine-fentanyl (Drug)
Bupivacaine-Fentanyl-Naloxone Spinal Anaesthesia
干预措施: Bupivacaine-fentanyl (Drug)
结局指标
主要结局
incidence of fentanyl - induced pruritus
时间窗: 4 hours postoperative
A four category verbal rating scale VRS-4 ( 0 to 3 scale ) which will be will be explained to all patients, where ( 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms ) with the basal preoperative value is being recorded.
次要结局
- postoperative nausea and vomiting(24 hours)
- Cognitive function using Mini Mental State Examination (MMSE) scoring(24 hours)
- The time for first postoperative analgesic requirements(24 hours)
研究者
Khaled Abdelfattah Abdallah Sarhan
lecturer of anesthesia,SICU and pain management
Kasr El Aini Hospital