Effect of Propofol Administration Time on the Incidence and Severity of Intrathecal Morphine-induced Pruritus in Parturient Undergoing Elective Cesarean Delivaries: A Prospective, Randomized, Comparative Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 204
- 主要终点
- severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.
研究概览
简要总结
Our hypothesis suggests that Administration time of intravenous propofol may affect Pruritus incidence and severity that occur after intrathecal morphine in parturient undergoing elective cesarean section (CS). the aim of the study is to investigate effect of prophylactic administration of intravenous sub-hypnotic dose of propofol before intrathecal morphine compared with the administration after intrathecal morphine on intrathecal morphine-induced pruritus incidence and severity in parturient undergoing elective cesarean delivaries.
详细描述
Neuraxial Anaesthesia is a frequent anaesthetic approach for cesarean delivery and other lower abdominal and lower limb anaesthetic procedures. Neuraxial morphine addition to local anaesthetic provides an effective and prolonged postoperative analgesia, but has been associated with a frequent incidence of pruritus and postoperative nausea and vomiting (PONV).
Neuraxial opioids are thought to act on central nervous system pathways to cause pruritus. Although precise mechanisms are incompletely understood, Numerous interventions have been investigated to prevent opioid-induced pruritus in the peripartum period as: Opioid receptor agonist-antagonists, Serotonin receptor antagonists.
There is dense concentration of opioid receptors and 5-HT3 receptors in the dorsal part of the spinal cord and nucleus of the spinal tract of the trigeminal nerve in the medulla. Activation of these receptors by neuraxial opioid administration or by circulating estrogen in parturient results in pruritus which is usually localized to face, neck, or upper thorax.
Propofol exerts its antipruritic action through inhibition of the posterior horn transmission in spinal cord. Series of clinical trials have reported that a sub-hypnotic dose of propofol is equally effective in reducing the incidence of pruritus following intrathecal morphine. however these studies have limited information about dose and timing of administration of propofol.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Parturient of American Society of Anaesthesiologists (ASA) class I or II physical status.
- •Age: 20-40 years.
- •At term gestation (≥ 37 weeks) with a singleton uncomplicated pregnancy.
- •Elective cesarean delivery under intrathecal anaesthesia
排除标准
- •Parturient refusal.
- •Significant organ dysfunctions (e.g., cardiac, respiratory, renal, or liver disorders).
- •Morbid obesity (BMI >35).
- •Parturient with known hypersensitivity to propofol, morphine or amide local anaesthetics.
- •Parturient with pruritogenic systemic disease.
- •A coexisting skin disorder or preexisting pregnancy induced pruritus.
- •Parturient with any contraindication for intrathecal anaesthesia, e.g. coagulopathy.
- •Emergency cesarean section.
- •Failed or unsatisfactory intrathecal block.
研究组 & 干预措施
Group A
Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
干预措施: Morphine intrathecal (Drug)
Group A
Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection 15 min before the end of surgery
干预措施: propofol (Drug)
Group B
Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
干预措施: Morphine intrathecal (Drug)
Group B
Patients will receive 0.5 mg/kg propofol diluted in 10 ml saline 0.9% IV injection just before intrathecal anaesthesia
干预措施: propofol (Drug)
Group C
patients will receive intrathecal anaesthesia with morphine without other intervention
干预措施: Morphine intrathecal (Drug)
结局指标
主要结局
severity of pruritus that occurs after intrathecal morphine in parturient undergoing elective cesarean section (CS) by pruritus Grading system.
时间窗: 24 hours
the pruritus grading score (PGS) score (Firas et al, 2012) for each patient which is based on: distribution, frequency, severity of itch, and quality of sleep Each patient's itch grade is calculated as the sum of the individual scores: Mild grade: if the total score is between 0 and 5. Moderate grade: if the total score is between 6 and 11. Severe grade: if the total score is between 12 and 19.
次要结局
未报告次要终点
研究者
Esraa Essam Elsayed Mohamed
resident doctor at Anaesthesia ,Intensive care & pain management Faculty of Medicine, Assiut University
Assiut University