Clinical trial NCT02123355: The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery
Official title: The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery,A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cognitive Ability, General
Brain Injury
Lead sponsor: Shaanxi Provincial People's Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Medical Association
First posted: 2014-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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; -

Primary outcomes:
measure: Change from baseline in cognitive function at 7 days
timeFrame: Baseline, the 7th day after the surgery
Secondary outcomes:
measure: Brain injury assessment
timeFrame: From entering the operating room to 48 hours after the surgery
measure: Inflammatory responsive assessment
timeFrame: From entering the operating room to 48 hours after the surgery
measure: Heart rate
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Depth of anesthesia
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Recovery of anesthesia
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Central venous pressure(CVP)
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Blood pressure
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Respiration rate
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Pulse blood oxygen saturation
timeFrame: From the induction of anesthesia to the right moment of extubation, up to 1 day.
measure: Number of Participants with Serious and Non-Serious Adverse Events
timeFrame: Up to 7 days
Other outcomes:
Locations:
Study officials:
References: