Status:
UNKNOWN
How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium
Lead Sponsor:
Shanghai Zhongshan Hospital
Collaborating Sponsors:
First Affiliated Hospital of Guangxi Medical University
The Second Affiliated Hospital of Harbin Medical University
Conditions:
Delirium in Old Age
Eligibility:
All Genders
65-90 years
Phase:
PHASE4
Brief Summary
the hypothesis is that Dexmedetomidine seems to decrease incidence of post-operative delirium . one possible mechanism is that Dex have a minor influence on cognition, since it has no effect on GABA r...
Detailed Description
With a complex etiology, delirium is usually caused by various peri-operative stimuli on basis of predisposing factors, including senility, hypoxia and hypotension, pain, drug (such as pethidine, benz...
Eligibility Criteria
Inclusion
- Acquisition of informed consent,
- Patients with hip fracture surgery under lumbar anesthesia,
- Grade II to III based on American Society of Anesthesiologists ASA classification,
- Age ≥65 and ≤90 years old.
Exclusion
- History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.
- More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.
- CAM positive diagnosed preoperatively.
- Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).
- Systolic pressure \< 90mmHg and diastolic pressure \< 60mm Hg at the preoperative follow up or HR\< 50/minute.
- History of heat failure or EF\<30% as shown by ultrasound cardiogram; degree 2 type 2 and degree 3 atrioventricular block. History of active heart disease (such as acute cardiac infarction, unstable angina pectoris)
- Severe abnormality in hepatic or renal function (severe abnormality in liver function: more than 2-times increase than upper normal limit in any one of the markers including ALT,, conjugated bilirubin, AST, ALP, total bilirubin; severe abnormality in renal function; Cr clearance\<30ml/min), Scr\>443μmol/L.
- Diabetes patients with severe complications of diabetes (Diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, and diabetic nephropathy)
- Patients with severe infection.
- Postoperative PaO2\<60mmHg or SpO2\<92%.
- Participation in clinical trials of other drugs within past 30 days.
- Disturbed verbal communication, and unable to accomplish the test on cognition.
- Patients with prosthesis fracture or restoration; hip fracture but complicated with severe trauma in other sites.
- Being allergic to investigational drug or having contradiction of lumbar anesthesia.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2019
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT03346226
Start Date
January 1 2018
End Date
June 30 2019
Last Update
December 13 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.