How Different Sedatives Affect Hip Fracture Patient's Postoperative Delirium

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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 receptor，another is that Dex could induce a sleep similar to natural sleep, thereby decreasing sleep deprivation and circadian rhythm disorder in post-operative patients.

In this study , investigators devise the two different sedatives(Dexmedetomidine and Propofol)'influence on postoperative delirium in hip fracture elderly participants under spinal anesthesia

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Beijing Jishuitan Hospital; First Affiliated Hospital of Guangxi Medical University; Foshan Hospital of Traditional Chinese Medicine; Qianfoshan Hospital; Second Hospital of Shanxi Medical University; Shanghai 6th People's Hospital; Shanghai Changzheng Hospital; Tang-Du Hospital; The First Affiliated Hospital of Nanchang University; The First Affiliated Hospital of Soochow University; The Fuzhou No 2 Hospital; The Second Affiliated Hospital of Harbin Medical University
• Treatments: Dexmedetomidine; Hypnotics and Sedatives; Propofol

Criteria

Inclusion Criteria:

1. Acquisition of informed consent,

2. Patients with hip fracture surgery under lumbar anesthesia,

3. Grade II to III based on American Society of Anesthesiologists ASA classification,

4. Age ≥65 and ≤90 years old.

Exclusion Criteria:

1. History of psychiatric disease or a disease needing long-term exposure to psychotropic drugs (dementia, schizophrenia), or history of alcoholic abuse.

2. More than 8 errors in preoperative Simplified Psychology and Mental Status Questionnaire (SPMSQ) , and diagnosed as severe cognitive impairment.

3. CAM positive diagnosed preoperatively.

4. Any cerebrovascular accident occurring within 3 months, such as cerebral stroke or transient ischemic attack (TIA).

5. Systolic pressure < 90mmHg and diastolic pressure < 60mm Hg at the preoperative follow up or HR< 50/minute.

6. 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)

7. 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.

8. Diabetes patients with severe complications of diabetes (Diabetic ketoacidosis, hyperosmolar coma, various infections, macrovascular diseases, and diabetic nephropathy)

9. Patients with severe infection.

10. Postoperative PaO2<60mmHg or SpO2<92%.

11. Participation in clinical trials of other drugs within past 30 days.

12. Disturbed verbal communication, and unable to accomplish the test on cognition.

13. Patients with prosthesis fracture or restoration; hip fracture but complicated with severe trauma in other sites.

14. Being allergic to investigational drug or having contradiction of lumbar anesthesia.