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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275182
• Other study ID #: 201401
• Status: Completed
• Phase: Phase 4
• First received: October 21, 2014
• Last updated: April 23, 2018
• Start date: October 2014
• Est. completion date: February 20, 2017

Study information

• Verified date: April 2018
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 864
• Est. completion date: February 20, 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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; -

Related Conditions & MeSH terms

• Confusion
• Delirium
• Postoperative Confusion

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Anqing Municipal Hospital	Anqing	Anhui
China	Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Affiliated Chaohu Hospital of Anhui Medical Hospital	Chaohu	Anhui
China	Binhu Hospital of Hefei	Hefei	Anhui
China	Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The first Hospital of Hefei	Hefei	Anhui
China	The Second Hospital of Hefei	Hefei	Anhui
China	The Second People's Hospital of Anhui	Hefei	Anhui
China	the people's Hospital of Liuan	Liuan	Anhui
China	the people's Hospital of Tongling	Tongling	Anhui
China	The First Affiliated Hospital of Wannan Medical College	Wuhu	Anhui
China	The second People's Hospital of Wuhu	Wuhu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of incidence of postoperative cognition dysfunction	The neuropsychological tests performed at the day before the surgery, the 3rd and 7th day after the surgery respectively.; A test environment to keep quiet, well-lit, non-interference, all the test items should be completed within 30 min.; Normal population (65 to 90 years age-matched 400 non-surgery people) should perform neuropsychological tests in the same time interval, then calculate the score difference(?Xc), and the standard deviation(SD) of the difference.; Calculate the difference(?X) between the score obtained before surgery and 3 or 7 days after the surgery (there are both positive and negative, we use the absolute value), with this difference( ?X) divided by the standard deviation(SD)of the difference of the normal population, that is ?X / SD and it is the Z score.; POCD Diagnosis: if a patient has two or more than two of the absolute value of Z scores =1.96, the POCD is exist.	1 day Before surgery,the 3rd,7th day after the surgery.
Primary	The change of incidence of postoperative delirium	Through CAM-ICU to assess the incidence of the postoperative delirium.	The first, second and third day after the surgery.
Primary	The change of Neuropsychological status	Through the Telephone Interview for Cognitive Status-Modified(TICS-m) to follow up.	the 3rd,6th month after the surgery
Secondary	The occurrence of cardiovascular events.		from begging of the anesthesia to the time the patients discharge, up to 1 month.
Secondary	The incidence of any adverse or severe adverse events.	Including kidney or brain related adverse events.	From the beginning of the admitted to 6 month after the surgery, up to 6 month.
Secondary	The variation of heart rate.	Heart rate is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
Secondary	The variation of blood pressure.	blood pressure is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
Secondary	the variation of pulse oxygen saturation.	Pulse oxygen saturation is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
Secondary	The monitor of depth of anesthesia.	Bispectral index (Bis) is recorded every 15 minutes during the anesthesia.	From the beginning to the end of anesthesia,up to 6 hours.
Secondary	The serum concentrations of BDNF	Serum level of brain-derived neurotrophic factor (BDNF) was measured	From the baseline to the 3-day,7-day and 1-month.