The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 80
- 主要终点
- Change from baseline in cognitive function at 7 days
研究概览
简要总结
The incidence of postoperative cognitive dysfunction (POCD) is high and POCD affect the life quality and the prognosis of patients. Geriatrics is the independent risk factor of POCD, and POCD is also correlated with many other factors such as type of surgery, the duration of anesthesia and the anesthesia drugs used et al. So, the prevention and treatment of POCD in geriatrics is important.
Dexmedetomidine is found to have the effect of neuro-protection, but it is controversy whether Dexmedetomidine has the effect of neuro-protection in geriatrics, especially the prolonged surgery.
The purpose of this study is to explore the effect of Dexmedetomidine to the cognitive function at prolonged surgery in geriatrics in geriatrics.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Scheduled for elective abdominal surgery
- •Weight is within the range of ±20% of standard weight [standard weight=Height(cm)-80)×70﹪ for male and(Height(cm)-70)×60﹪] for female
- •American society of anesthesia classification I~III
- •Expected time of surgery is more than 4 hours -
排除标准
- •Systolic blood pressure≥180 mm Hg or <90 mm Hg，diastolic blood pressure≥110 mm Hg or < 60 mm Hg；
- •Serious cardiac,liver,kidney,lung, endocrine disease or sepsis.
- •Allergy to trial drug or other contraindication；
- •Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation
- •History of mental illness and cerebral vascular disease
- •History of unstable angina or myocardial infarction
- •Education level<7 yrs
- •Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders.
- •Abuse of narcotic analgesia or suspected;
- •Neuromuscular diseases;
- •Mentally unstable or has a mental illness;
- •Pregnant or breast-feeding women;
- •Attended other trial past 30 days; -
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Induction of anesthesia (Drug)
Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Intubation (Procedure)
Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Sevoflurane, remifentanil ,vecuronium (Drug)
Dexmedetomidine
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Dexmedetomidine (Drug)
Normal saline
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Induction of anesthesia (Drug)
Normal saline
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Intubation (Procedure)
Normal saline
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Sevoflurane, remifentanil ,vecuronium (Drug)
Normal saline
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in cognitive function at 7 days
时间窗: Baseline, the 7th day after the surgery
1. Modified Newman scale to assess the cognitive function, including five tests. 2. The quiet environment, enough daylight, no disturb is needed when the modified Newman scale is done. All the five tests are finished within 30 min. 3. all the score of each test of all the patients assessed before the surgery is calculated, then get the standard variation, the score of each subject of each test is compared with the standard deviation, if one or more stand deviation decrease, then the cognitive function is considered as deterioration . 4. When 2 or more of the tests is considered as deterioration, then the patients is diagnosed as Post Operation Cognitive Dysfunction (POCD).
次要结局
- Inflammatory responsive assessment(From entering the operating room to 48 hours after the surgery)
- Brain injury assessment(From entering the operating room to 48 hours after the surgery)
- Depth of anesthesia(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Recovery of anesthesia(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Respiration rate(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Pulse blood oxygen saturation(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Number of Participants with Serious and Non-Serious Adverse Events(Up to 7 days)
- Heart rate(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Central venous pressure(CVP)(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
- Blood pressure(From the induction of anesthesia to the right moment of extubation, up to 1 day.)
研究者
Yang Li
Anesthesiologist
Shaanxi Provincial People's Hospital