Effect of Intravenous Magnesium on Post-spinal Fentanyl Induced Pruritus Incidence; A Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Incidence of pruritus in each group incidence %.
研究概览
简要总结
Introduction: Adding opioids to local anesthetic solutions leads to enhanced anesthesia and provide postoperative analgesia. Intrathecaly injected opioids have some side effects, though. One of them is pruritus. Objective: We designed a randomized, double-blinded, placebo-controlled study to evaluate prophylactic impact of continuous IV Magnesium 10mg/kg over 30 minutes on intrathecal fentanyl-induced pruritus start at the end of the operation.
Methods: ASA I-II Patient's candidate for orthopedic operations under spinal anesthesia (10-15mg hyperbaric bupivacaine and 25 µg fentanyl intrathecal) and will be divided randomly into two groups:
Control group (Placebo group): bolus 100 ml nacl 0.9% at end of surgery Study group (Mg ++ group): (continuous IV Magnesium 10mg/kg in 100 ml Nacl0.9% over 30 minutes at end of surgery).
Study outcome:
- Hemodynamics: Systolic blood pressure, Mean arterial blood pressure, pulse rate, O2 saturation will be recorded in 5 min,10 min,30 min,60 min and every one hour till 6 hours after the operation.
- Pruritus Patients were asked about existence (present=1,no=0), severity (mild=1, modret=2, sever =3) and site of pruritus (Face(trigeminal) =1, neuroaxial(dermatome)=2), 1,2,4, and 6 hours after operation. Incidence of pruritus total group incidence %.
- The incidence of PONV.
详细描述
Study hypothesis Intravenous Magnesium would reduce and improve post-spinal fentanyl pruritus incidence outcome relaying up on the fact that Magnesium ions block the neuroaxial NMDA receptor which are involved in histamine-induced expansion of mechanical receptive field area, a neural event possibly involved in the development of pruritis. (36) Aim of the work To introduce Magnesium sulphate as cheap effective alternative for prevention and management of post-spinal opioid pruritis.
Methods This prospective randomized double blinded controlled study will be carried out in Mansoura faculty of medicine in Mansoura University hospital on cases subjected to LL orthopedic operations under spinal anesthesia utilizing bupivacaine plus adjuvant fentanyl which is documented to have high incidence of postspinal pruritus.
Patients: ASA I-II, of both genders, aged 20-70 years old Patient's candidate for LL orthopedic operations under spinal anesthesia. Total patient number of 144, will be enrolled into two groups 72 patients each, all patients will be anesthetized intrathecaly using10-15mg hyperbaric bupivacaine and 30 µg fentanyl and will be subdivided randomly into two groups:
Control group (Placebo Group): bolus 50 ml Nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.
Study group (MG++ Group): continuous IV infusion pump of Magnesium 10mg/kg in 50 ml Nacl0.9% over 20 minutes at end of surgery 5ml/minute infusion rate.
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, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II Both genders Aged 20-70 years old Patient's candidate for LL orthopedic operations under spinal anesthesia
排除标准
- •BMI>35 Patient refusal Hypersensitivity to amide local anesthetics Fentanyl opioids Magnesium and naloxone. Patients with LBBB and trifacicular block General contraindications to spinal anesthesia surgeon total refusal Cardiac, hepatic, renal or respiratory failure Difficult communication with the patient (psychological or deafness).
研究组 & 干预措施
Placebo group
bolus 50 ml nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.
干预措施: IV infusion (Drug)
Placebo group
bolus 50 ml nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.
干预措施: intrathecal fentanyl (Drug)
IV Mg ++ group
continuous IV infusion pump of Magnesium 10mg/kg in 50 ml Nacl0.9% over 20 minutes at end of surgery 5ml/minute infusion rate.
干预措施: IV infusion (Drug)
IV Mg ++ group
continuous IV infusion pump of Magnesium 10mg/kg in 50 ml Nacl0.9% over 20 minutes at end of surgery 5ml/minute infusion rate.
干预措施: intrathecal fentanyl (Drug)
结局指标
主要结局
Incidence of pruritus in each group incidence %.
时间窗: during the 1st 6 hours after spinal fentanyl injection.
Existence,Severity, Site of pruritus (Face (trigeminal) =1, neuraxial (dermatome) =2)
次要结局
未报告次要终点
研究者
Mohamed Abd Latif Ghanim
Associate Professor os anesthesia ICU & Pain medicine.
Mansoura University