Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- total dose of intravenous PCA morphine consumption in the first 48 h postoperative
研究概览
简要总结
The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.
详细描述
Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)
排除标准
- •known allergy to study drugs
- •Significant cardiac, respiratory, renal or hepatic disease.
- •2nd or 3rd degree heart block.
- •Coagulation disorders.
- •Low back pain or other back problems.
- •Drug or alcohol abuse.
- •BMI>30kg\m
- •Psychiatric illnesses that would interfere with perception and assessment of pain.
研究组 & 干预措施
Intrathecal Bupivacaine
intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%
干预措施: Bupivacaine (Drug)
Intrathecal Morphine
intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume
干预措施: Bupivacaine (Drug)
Intrathecal Morphine
intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume
干预措施: Morphine (Drug)
Intrathecal Morphine-Dex
intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
干预措施: Dexmedetomidine (Precedex) (Drug)
Intrathecal Morphine-Dex
intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
干预措施: Bupivacaine (Drug)
Intrathecal Morphine-Dex
intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
干预措施: Morphine (Drug)
结局指标
主要结局
total dose of intravenous PCA morphine consumption in the first 48 h postoperative
时间窗: 48 hours
Calculating the cumulative intravenous PCA morphine dose
次要结局
- Noninvasive blood pressure(48 hours)
- time to first request for analgesia(48hours)
- Heart rate(48 hours)
- postoperative VAS scores(48 hours)
- peripheral arterial oxygen saturation(48 hours)
研究者
Khaled Mohamed Fares
Professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt.
Assiut University