Long-term Outcome of General Anesthesia on Dysgnosia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Delirium, Dementia, Amnestic, Cognitive Disorders	Drug: Sevoflurane Drug: Propofol	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia

Resource links provided by NLM:

MedlinePlus related topics: Delirium Dementia

Drug Information available for: Propofol Sevoflurane

U.S. FDA Resources

Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:

Cognitive ability [ Time Frame: The 10th year since postoperation ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory

Secondary Outcome Measures:

Cognitive ability [ Time Frame: One hour before operation ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability [ Time Frame: Immediately after operation (0 day) ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability [ Time Frame: One month after operation ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability [ Time Frame: Six month after operation ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability [ Time Frame: One year after operation ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
Cognitive ability [ Time Frame: Once a year from the 1st year after operation up to 9th year ] [ Designated as safety issue: Yes ]
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory

Estimated Enrollment:	10000
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2020
Estimated Primary Completion Date:	August 2020 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Local anesthesia Patients received local anesthesia without any intervention of general anesthetics
Active Comparator: Inhalational anesthesia Patients received sevoflurane anesthesia during general anesthesia	Drug: Sevoflurane 1-8% sevoflurane for maintaining the whole period of general anesthesia Other Name: Sevorane
Active Comparator: Intravenous anesthesia Patients received intravenous anesthetic (Propofol) during general anesthesia	Drug: Propofol 1-4 mg/kg/h of propofol during the whole period of general anesthesia Other Name: Diprivan

Eligibility

Ages Eligible for Study:	10 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184638

Contacts

Contact: FuZhou Wang, PhD MD	86 25 84460777 ext 3301	zfwang50@gmail.com
Contact: XiaoFeng Shen, MPH, MD	86 25 84460777 ext 3303	sxf0418@njmu.edu.cn

Locations

China, Jiangsu
Nanjing Maternity and Child Health Care Hospital	Recruiting
Nanjing, Jiangsu, China, 210004
Contact: YuZhu Peng, MD 86 25 84460777 ext 1508 pyz1131@hotmail.com
Contact: XiRong Guo, MD 86 25 84460777 ext 1508 xrguonjmueducn@yahoo.com.cn
Sub-Investigator: ShiQin Xu, MD

Sponsors and Collaborators

Nanjing Medical University

Investigators

Study Director:

FuZhou Wang, PhD MD

Nanjing Medical University

More Information

No publications provided

Responsible Party:	FuZhou Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:	NCT01184638 History of Changes
Other Study ID Numbers:	NJMU-2010-07022, NJFY7M12
Study First Received:	August 16, 2010
Last Updated:	May 10, 2011
Health Authority:	China: Ethics Committee

Keywords provided by Nanjing Medical University:

Cognitive Disorders
General anesthesia
Sevoflurane
Propofol
Memory

Additional relevant MeSH terms:

Cognition Disorders
Delirium
Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Anesthetics

Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on May 19, 2013

Long-term Outcome of General Anesthesia on Dysgnosia (LOGAND)