Comparison of CRP Levels, Neutrophil Count, and Clinical Outcomes of Low Dose Ketamine Between at Anesthesia Induction and at the End of Surgery in Patients Undergo Elective Laparotomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- serum neutrophil-count
研究概览
简要总结
The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.
详细描述
The effects of anesthesia and surgery can lead to stress responses that result in hormonal and metabolic changes in the body. The immune system and the nervous system communicate both ways, and it was found that nociception and proinflammatory cytokines play a joint regulatory role, i.e., increased production of proinflammatory cytokines can worsen the pain. Major surgery can trigger the release of cytokines such as IL-1, IL-6, and TNF-α.
The acute analgesic effect of ketamine is generally believed to be mediated through the blockade of the phencyclidine binding site of the N-methyl-d-aspartate (NMDA) receptor of nociceptive neurons. Ketamine can reduce the inflammatory response marked by a decrease in CRP levels to surgical trauma and can prevent secondary damage to tissues/organs that were not initially affected by surgery by reducing inflammation. This also reduces postoperative pain and analgesics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only care providers involved directly with the subjects in the operating room are not masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparotomy with general anesthesia at Sanglah Hospital from July to September
- •Patients aged 18-65 years.
- •Patient physical status American American Society of Anesthesiologist (ASA) 1 and 2.
排除标准
- •Contraindication to ketamine.
- •Allergy to morphine
- •Presence of cardiorespiratory chronic diseases.
- •Presence of autoimmune diseases.
- •History of the central nervous system or psychiatric disorders.
- •BMI <18.5 kg/m2 or ≥30 kg/m
- •A history of chronic pain killer medications (such as opioid or non-steroidal anti- inflammatory drugs)
- •Drop Out Criteria
- •Patients with class 3 bleeding during the surgery
- •Patients with more than 5-hours duration of surgery
- •Patients need mechanical ventilation after the surgery
研究组 & 干预措施
End-of-surgery
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
干预措施: Ketamine 0.3 mg/kg at end-of-surgery (Drug)
End-of-surgery
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at the end of surgery
干预措施: Ketamine 0.3 mg/kg at anesthesia induction (Drug)
Induction
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction
干预措施: Ketamine 0.3 mg/kg at end-of-surgery (Drug)
Induction
Low-dose ketamine (0.3 mg/kg) in 3 ml normal saline solution given at induction
干预措施: Ketamine 0.3 mg/kg at anesthesia induction (Drug)
结局指标
主要结局
serum neutrophil-count
时间窗: 24-hours after surgery
serum neutrophil-count (from a complete blood count test)
Serum CRP level
时间窗: 24-hours after surgery
Serum C-reactive protein level
VAS (visual analog score)
时间窗: first 24 hours after the surgery
minimum=0; maximum=10; higher score corresponds to more severe pain
morphine consumption (mg)
时间窗: first 24 hours after the surgery
total morphine consumption in 24 hours after the surgery
次要结局
未报告次要终点
研究者
Christopher Ryalino
Principal Investigator
Udayana University