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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 18 April 2017
Main ID:  ChiCTR-TRC-08000187
Date of registration: 2008-11-15
Prospective Registration: No
Primary sponsor: Beijing Friendship Hospital, Capital Medical University
Public title: The effect of anesthetic on postoperative cognitive dysfunction and relative protein in CSF in elder
Scientific title: The effect of anesthetic on postoperative cognitive dysfunction and relative protein in CSF in elder
Date of first enrolment: 2008-01-01
Target sample size: SI group:15;S group:15;SP group:15;SD group:15;
Recruitment status: Completed
URL:  http://www.chictr.org.cn/showproj.aspx?proj=9338
Study type:  Interventional study
Study design:  Randomized parallel controlled trial  
Phase:  I (Phase I study)
Countries of recruitment
China
Contacts
Name: Bin Zhang   
Address:  No. 95, Yongan Road, Xuanwu District, Beijing, China 100050
Telephone: +86 0 13901111862
Email: shuibingzb@hotmail.com
Affiliation:  Beijing Friendship Hospital, Capital Medical University
Name: Bin Zhang   
Address:  No. 95, Yongan Road, Xuanwu District, Beijing, China 100050
Telephone: +86 0 13901111862
Email: shuibingzb@hotmail.com
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Patients aged from 65-75 years old and schedule to undergo lower limb or hypogastrium operation; ASA I-II; without mental or neurologic disease;educated; no disorder in auditus, vision and language. And all patients accept continuous spinal anesthesia.
Exclusion criteria: Patients will be excluded when
(1) They are over 75 yrs or below 65 yrs;
(2) They can't accept continuous spinal anesthesia;
(3) They have mental or neurologic disease;
(4) ASA III or higher;
(5) They have contraindication to relative drug;
(6) They have anxiety-depression or severe complication after operation;
(7)They are taking part in other trial.


Age minimum: 65
Age maximum: 75
Gender: Both
Health Condition(s) or Problem(s) studied
Alzheimer disease; Postoperative cognitive dysfunction.
Intervention(s)
SI group:After continuous spinal anesthesia is stable, we inject propofol 2mg/kg, then insert LMA and make 1-1.5MAC isoflurane inhaled 2 hours continuously to maintain BIS between 50-60, remaining spontaneously breathing, collecting CSF 1-1.5ml before and 2 hours after isoflurane inhalation, respectively. ;S group:Continuous spinal anesthesia only. Collecting CSF 1-1.5ml before and 2 hours after anesthesia respectively. ;SP group:After continuous spinal anesthesia is stable, inject propofol 2mg/kg, then insert LMA and infuse propofol 2 hours continuously to maintain BIS between 50-60, remaining spontaneously breathing, collecting CSF 1-1.5ml before and 2 hours after propofol infusing, respectively. ;SD group:After continuous spinal anesthesia is stable, inject propofol 2mg/kg, then insert LMA and make 1-1.5MAC desflurane inhaled 2 hours continuously to maintain BIS between 50-60, remaining spontaneously breathing, collecting CSF 1-1.5ml before and 2 hours after desflurane inhalation respectively;
Primary Outcome(s)
A beta 40 and A beta 42 in CS;
Secondary Outcome(s)
IL-1beta, TNF-alpha, S100 beta, NSE in CS;
Secondary ID(s)
Source(s) of Monetary Support
Beijing Friendship Hospital, Capital Medical University
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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