ISRCTN13642102
Completed
Phase 4
Effect of dexmedetomidine on delirium and postoperative cognitive dysfunction in patients undergoing orthopedic or vascular surgery under regional anesthesia
niversity of Crete0 sites80 target enrollmentApril 27, 2020
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Sedation during regional anaesthesia
- Sponsor
- niversity of Crete
- Enrollment
- 80
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Undergoing orthopaedic or vascular surgery under regional anaesthesia
- •2\. Age \>65 years
- •3\. Medical history and preoperative anaesthetic assessment to allow regional anesthesia to be used
- •4\. Must know writing and reading
- •5\. Remain in the hospital for at least four days
- •6\. Expected postoperative survival is at least one year (on malignant neoplasms) and with a small chance of re\-operation within three months
Exclusion Criteria
- •1\. Refuse to receive regional anesthesia or to participate in the study
- •2\. Central nervous system disease (infectious, metabolic, degenerative, neoplastic, or major psychosis)
- •3\. Severe vision or hearing impairment
- •4\. Alcoholics or drug abusers
- •5\. Severe general condition or in end\-stage neoplasm
- •6\. Contraindications for regional anaesthesia:
- •6\.1\. Coagulation disorders:
- •6\.1\.1\. INR\> 1\.4
- •6\.1\.2\. Platelet count \<100,000 / µl
- •6\.1\.3\. Active/uncontrolled bleeding
Outcomes
Primary Outcomes
Not specified
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