The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery

Shaanxi Provincial People's Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Cognitive Ability, General Brain Injury

Interventions

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Written informed consent 2. Scheduled for elective abdominal surgery 3. Age≥65 yrs 4. 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 5. American society of anesthesia classification I\~III 6. Expected time of surgery is more than 4 hours - Exclusion Criteria: 1. Systolic blood pressure≥180 mm Hg or \<90 mm Hg，diastolic blood pressure≥110 mm Hg or \< 60 mm Hg； 2. Serious cardiac,liver,kidney,lung, endocrine disease or sepsis. 3. Allergy to trial drug or other contraindication； 4. Difficult airway occurred before,or difficult airway possibly occurred and difficult to extubation 5. History of mental illness and cerebral vascular disease 6. History of unstable angina or myocardial infarction 7. Education level\<7 yrs 8. Factors existed that affect cognition assessment such as language, visual sense,auditory sense disorders. 9. Abuse of narcotic analgesia or suspected; 10. Neuromuscular diseases; 11. Mentally unstable or has a mental illness; 12. Pregnant or breast-feeding women; 13. Attended other trial past 30 days; -

Outcomes

Primary Outcomes

Change from baseline in cognitive function at 7 days

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).

Time frame: Baseline, the 7th day after the surgery

Secondary Outcomes

Brain injury assessment

1. 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery. 2. The serum level of C-reaction protein(CRP),tumor necrosis factor(TNF-α)、interleukin-6（IL-6）,interleukin-10（IL-10) is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA)

Time frame: From entering the operating room to 48 hours after the surgery

Inflammatory responsive assessment

1. 2 ml blood sample is collected at 8 time points including before surgery,the right moment,2 hr and 4 hr after the induction, the right moment,12,24 and 48 hours after the surgery. 2. The concentration of protein S100B（S100B）and neuron specific enolase (NSE）in serum is tested using immunohistochemical double antibody sandwich enzyme-linked immunosorbent assay (ELISA).

Time frame: From entering the operating room to 48 hours after the surgery

Heart rate

Heart rate are monitored every 15 min from the induction of anesthesia to the right moment of extubation.