Long-term Outcome of General Anesthesia on Dysgnosia

Cognitive Disorders Clinical Trial

— LOGAND  

Official title:

Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01184638
• Other study ID #: NJMU-2010-07022
• Secondary ID: NJFY7M12
• Status: Recruiting
• Phase: Phase 4
• First received: August 16, 2010
• Last updated: January 11, 2014
• Start date: August 2010
• Est. completion date: August 2020

Study information

• Verified date: January 2014
• Source: Nanjing Medical University
• Contact: FuZhou Wang, PhD MD
• Phone: 86 25 84460777
• Email: zfwang50[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amnestic,
• Cognition Disorders
• Cognitive Disorders
• Delirium,
• Dementia,

Intervention

Drug:
• Sevoflurane
1-8% sevoflurane for maintaining the whole period of general anesthesia
• Propofol
1-4 mg/kg/h of propofol during the whole period of general anesthesia

Locations

Country	Name	City	State
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	The 10th year since postoperation	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	One hour before operation	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	Immediately after operation (0 day)	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	One month after operation	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	Six month after operation	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	One year after operation	Yes
Secondary	Cognitive ability	Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory	Once a year from the 1st year after operation up to 9th year	Yes