NCT01115179已完成4 期
Propofol and/or Its Solvent Modify the Course of Inflammatory Response After Surgical Stress: A Randomized, Controlled, Double-blind Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Apolipoprotein A-I level
研究概览
简要总结
The inflammatory properties of propofol are still under debate. Apolipoprotein A-I (Apo A-I) is involved in the inflammatory process. This study was designed to determine whether and how propofol or its solvent modulate Apo A-I and the inflammatory response after surgical stress. The investigators study hypothesis was that propofol might modify the Apo A-I blood levels, and thus, modulate the postoperative inflammatory course.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •American Society of Anesthesiologists (ASA) I or II
- •scheduled for uni- or bilateral elective laparoscopic totally extraperitoneal hernia repair
排除标准
- •Body mass index (BMI) < 18.5 or > 39.9kg/m2
- •treatments with steroids (>5mg/d prednisone equivalent, for the last 30 days)
- •with opioids/non-steroidal anti-inflammatory drugs (NSAIDs) for chronic pain during the last 30 days
- •immunosuppression (AIDS, neutropenia <1000 cells/ml, transplant surgery, chemotherapy)
- •known lipid disorder (triglycerides >2.00mmol/l, low-density lipoprotein (LDL)-cholesterol >2.50mmol/l or high-density lipoprotein (HDL)-cholesterol < 1.00mmol/l)
- •hypolipemic treatment before admission
- •thyroid metabolism disorder (thyroid-stimulating hormone >6.0 mUI/l or <0.4mUI/l)
- •renal insufficiency (creatinine >106umol/l)
- •liver disorder (bilirubin >20umol/l, thromboplastin time <60%)
- •insulin dependant diabetes
- •parenteral nutrition or after any lipid-containing medication (propofol, intralipid, etomidate) during the last 30 days
- •antihypertensive medication with diltiazem or other calcium channel blockers
- •known chronic alcoholism (men: >65-75 ml alcohol/day)
- •multidrug abuse (cocaine, heroin, methadone, or other narcotics, sedatives or stimulants)
- •mental illness
- •known allergy to propofol after randomization:
- •change of surgical strategy
- •protocol violation
- •major bleeding (>0.5l)
研究组 & 干预措施
Propofol
Active Comparator
Propofol anesthesia
干预措施: propofol (Drug)
Control
Active Comparator
Anesthesia with isoflurane alone
干预措施: Saline (Drug)
Solvent
Active Comparator
Anesthesia with isoflurane together with the solvent of propofol (intralipid)
干预措施: Intralipid 10% (Drug)
结局指标
主要结局
Apolipoprotein A-I level
时间窗: 24 hours after surgery
次要结局
- Interleukin-6 level(5 hours after surgery)
- C-reactive protein (CRP) level(24 hours after surgery)
- Cortisol level(15 min after induction of anesthesia)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
The mechanism of action of anti-inflammatory effects of propofol in macrophagessepsis acute_respiratory_distress_syndrome surgical stressJPRN-UMIN000019625Juntendo university6
已完成
3 期
Use of a Modified Propofol Emulsion in AdultsAnesthesiaNCT00690495B. Braun Melsungen AG100
招募中
3 期
Comparison effects and Complications of propofol and isoflurane anesthesia for open cholecystectomyGallstone disease.Disease of gallbladder, unspecifiedK82.9IRCT20120817010617N6Zahedan University of Medical Sciences60
已完成
不适用
Comparison of Propofol, Etomidate and a combination of both on the hemodynamic responseCTRI/2020/11/029445Vidarshna V126
已完成
不适用
Influence of opioid on the relationship between effect-site concentration of propofol at loss of response and that at maintenance of anesthesiabreast tumor and gall stoneJPRN-UMIN000042785Kansai Medical University90