NCT02275182

Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients

Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 864 (actual)
• Sponsor: The First Affiliated Hospital of Anhui Medical University · Academic / Other
• Sex: All
• Age: 65 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Post-Operative Cognition Dysfunction (POCD) is a common complication after surgery, POCD can lead to a reduced ability and seriously affect the quality of life of patients, increase personal and social burden, POCD may also increase mortality.POCD can occur at any age, but the long-term, affect the daily lives of POCD in elderly patients over 60 years of age are more prone. Age is a risk factor for advanced or long-term POCD. POCD determined by preoperative cognitive function and psychological scales postoperative assessment, the main recommendation of the agreed test methods include, Rey auditory verbal test, the connection test, digit span test. In this study, preoperative mini-mental state examination (MMSE) screening, comprehensive neurological function during hospitalization for memory, attention, executive function and exercise capacity test, and telephone follow-up after discharge Scale Revised (TICS-M) test. Few study showed that dexmedetomidine may improve cognitive function in young patients others show that dexmedetomidine did not reduce POCD incidence after 24 hours of surgery. These results conflict and it is necessary to carry out large-scale, multi-center, randomized, controlled clinical study to determine whether dexmedetomidine reduce the POCD incidence or not for elderly patients.

Conditions

• Postoperative Confusion
• Delirium

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
DRUG	Saline	0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-01-01
• Completion: 2017-02-20
• First posted: 2014-10-27
• Last updated: 2018-04-25

Locations

13 sites across 1 country: China