The Effect of Dexmedetomidine to Cognition of Geriatrics in Prolonged Surgery
1 other identifier
interventional
80
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2014
CompletedFirst Posted
Study publicly available on registry
April 25, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedApril 25, 2014
April 1, 2014
Same day
April 20, 2014
April 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline, the 7th day after the surgery
Secondary Outcomes (10)
Brain injury assessment
From entering the operating room to 48 hours after the surgery
Inflammatory responsive assessment
From entering the operating room to 48 hours after the surgery
Heart rate
From the induction of anesthesia to the right moment of extubation, up to 1 day.
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.
- +5 more secondary outcomes
Study Arms (2)
Dexmedetomidine
EXPERIMENTALDexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Normal saline
SHAM COMPARATORNormal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Interventions
Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection
After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35\~40 mmHg，pulse oxygen saturation is more than 95%.
Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.
Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Scheduled for elective abdominal surgery
- Age≥65 yrs
- 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 -
You may not qualify if:
- 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; -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shaanxi Provincial People's Hospitallead
- Chinese Medical Associationcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesiologist
Study Record Dates
First Submitted
April 20, 2014
First Posted
April 25, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
April 25, 2014
Record last verified: 2014-04