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Long-term POCD after Laparoscopic Cholecystectomy
NCT02301676Phase 4
Key facts
- Status
- Unknown
- Start
- Dec 2014
- Primary completion
- Dec 2016
- Sponsor
- Pusan National University Hospital
- Modality
- Small Molecules
- Conditions
- gallbladder disease
01
Overview
Phase 4, open-label trial of sevoflurane, propofol and dexmedetomidine in gallbladder disease (2 arms), sponsored by Pusan National University Hospital. Primary endpoint: The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients at 2 years. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
General anesthesia & Control
Spouse control group assessed for cognitive function
Sevoflurane & Propofol & Dexmedetomidine
Patients undergoing laparoscopic cholecystectomy with one of the anesthetic methods
03
Who it enrols
Elderly patients (>= 60 years) scheduled for laparoscopic cholecystectomy under general anesthesia. Excludes patients with CNS diseases (dementia MMSE <24), use of tranquilizers/antidepressants, previous neuropsychological testing, Parkinson's disease, severe sensory handicap, illiteracy, alcoholism, or drug dependence.
04
Endpoints
Primary
The incidence of long-term postoperative cognitive dysfunction after general anesthesia in elderly patients
Secondary
The difference of incidence in postoperative cognitive dysfunction after general anesthesia according to the anesthetic drugs
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