Back to resultsLong-term Outcome of General Anesthesia on Dysgnosia (LOGAND)
Primary Purpose
Delirium,, Dementia,, Amnestic,
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
About this trial
This is an interventional treatment trial for Delirium, focused on measuring Cognitive Disorders, General anesthesia, Sevoflurane, Propofol, Memory
Eligibility Criteria
Inclusion Criteria:
- Patients with informed consents
- Without basal disorders of neurology and psychiatrics
Exclusion Criteria:
- With the history of cognitive disorders
- With chronic neurological disorders
- Cannot communicate with investigators
- Cannot stand general anesthesia
Sites / Locations
- Nanjing Maternity and Child Health Care HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Active Comparator
Arm Label
Local anesthesia
Inhalational anesthesia
Intravenous anesthesia
Arm Description
Patients received local anesthesia without any intervention of general anesthetics
Patients received sevoflurane anesthesia during general anesthesia
Patients received intravenous anesthetic (Propofol) during general anesthesia
Outcomes
Primary Outcome Measures
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Secondary Outcome Measures
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Full Information
NCT ID
NCT01184638
First Posted
August 16, 2010
Last Updated
January 11, 2014
Sponsor
Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01184638
Brief Title
Long-term Outcome of General Anesthesia on Dysgnosia
Acronym
LOGAND
Official Title
Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium,, Dementia,, Amnestic,, Cognitive Disorders
Keywords
Cognitive Disorders, General anesthesia, Sevoflurane, Propofol, Memory
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local anesthesia
Arm Type
No Intervention
Arm Description
Patients received local anesthesia without any intervention of general anesthetics
Arm Title
Inhalational anesthesia
Arm Type
Active Comparator
Arm Description
Patients received sevoflurane anesthesia during general anesthesia
Arm Title
Intravenous anesthesia
Arm Type
Active Comparator
Arm Description
Patients received intravenous anesthetic (Propofol) during general anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Sevorane
Intervention Description
1-8% sevoflurane for maintaining the whole period of general anesthesia
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Diprivan
Intervention Description
1-4 mg/kg/h of propofol during the whole period of general anesthesia
Primary Outcome Measure Information:
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
The 10th year since postoperation
Secondary Outcome Measure Information:
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
One hour before operation
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
Immediately after operation (0 day)
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
One month after operation
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
Six month after operation
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
One year after operation
Title
Cognitive ability
Description
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Time Frame
Once a year from the 1st year after operation up to 9th year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with informed consents
Without basal disorders of neurology and psychiatrics
Exclusion Criteria:
With the history of cognitive disorders
With chronic neurological disorders
Cannot communicate with investigators
Cannot stand general anesthesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
FuZhou Wang, PhD MD
Phone
86 25 84460777
Ext
3301
Email
zfwang50@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
XiaoFeng Shen, MPH, MD
Phone
86 25 84460777
Ext
3303
Email
sxf0418@njmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
FuZhou Wang, PhD MD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing Maternity and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
YuZhu Peng, MD
Phone
86 25 84460777
Ext
1508
Email
pyz1131@hotmail.com
First Name & Middle Initial & Last Name & Degree
XiRong Guo, MD
Phone
86 25 84460777
Ext
1508
Email
xrguonjmueducn@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
ShiQin Xu, MD
12. IPD Sharing Statement
Learn more about this trial
Long-term Outcome of General Anesthesia on Dysgnosia
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