Clinical trial NCT02275182: Impact of Dexmedetomidine on the Post-Operative Cognition Dysfunction(POCD) in Geriatric Patients
Official title: Impact of Dexmedetomidine Sedation on the Post-Operative Cognition Dysfunction--a Multiple Center,Randomized, Controlled,Double Blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Confusion
Delirium
Keywords: Dexmedetomidine
Lead sponsor: The First Affiliated Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2014-10-27
Enrollment: 864
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent
2. Selective surgery and general anesthesia patients(abdomen,orthopedics and urology surgery is preferred）；
3. Age 65-90 yrs；
4. Anesthesia Society of American (ASA) Scale II\~III；
5. Anticipated surgery time 2-6 hrs； -

Exclusion Criteria:

1. Dementia patients（Mini-mental state examination\< 20）
2. Factors existed that affect cognition assessment such as language,visual,and auditory dysfunction；
3. Unstable metal status and mental disease；
4. The cognitive function examination in 3-6 months is not anticipated to be completed
5. II-III Atrioventricular block；
6. Heat rate \< 50 beats/minutes；
7. Parkinson's Disease；
8. May occur or have occurred the difficult airway or anticipated delayed extubation
9. Sure or suspected abuse of analgesic and sedation drug；
10. Allergic to the trial drug and other anesthesia drug contraindication； -

Primary outcomes:
measure: The change of incidence of postoperative cognition dysfunction
timeFrame: 1 day Before surgery,the 3rd,7th day after the surgery.
measure: The change of incidence of postoperative delirium
timeFrame: The first, second and third day after the surgery.
measure: The change of Neuropsychological status
timeFrame: the 3rd,6th month after the surgery
Secondary outcomes:
measure: The occurrence of cardiovascular events.
timeFrame: from begging of the anesthesia to the time the patients discharge, up to 1 month.
measure: The incidence of any adverse or severe adverse events.
timeFrame: From the beginning of the admitted to 6 month after the surgery, up to 6 month.
measure: The variation of heart rate.
timeFrame: From the beginning to the end of anesthesia,up to 6 hours.
measure: The variation of blood pressure.
timeFrame: From the beginning to the end of anesthesia,up to 6 hours.
measure: the variation of pulse oxygen saturation.
timeFrame: From the beginning to the end of anesthesia,up to 6 hours.
measure: The monitor of depth of anesthesia.
timeFrame: From the beginning to the end of anesthesia,up to 6 hours.
measure: The serum concentrations of BDNF
timeFrame: From the baseline to the 3-day,7-day and 1-month.
Other outcomes:
Locations:
city: Anqing
country: China
facility: Anqing Municipal Hospital
state: Anhui
city: Bengbu
country: China
facility: Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Chaohu
country: China
facility: Affiliated Chaohu Hospital of Anhui Medical Hospital
state: Anhui
city: Hefei
country: China
facility: Binhu Hospital of Hefei
state: Anhui
city: Hefei
country: China
facility: Second Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Hefei
country: China
facility: The first Hospital of Hefei
state: Anhui
city: Hefei
country: China
facility: The Second Hospital of Hefei
state: Anhui
city: Hefei
country: China
facility: The Second People's Hospital of Anhui
state: Anhui
city: Liuan
country: China
facility: the people's Hospital of Liuan
state: Anhui
city: Tongling
country: China
facility: the people's Hospital of Tongling
state: Anhui
city: Wuhu
country: China
facility: The First Affiliated Hospital of Wannan Medical College
state: Anhui
city: Wuhu
country: China
facility: The second People's Hospital of Wuhu
state: Anhui
Study officials:
affiliation: The First Affiliated Hospital of Anhui Medical University
name: Wei Er Gu
role: PRINCIPAL_INVESTIGATOR
References: