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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Nanjing Medical University
Sponsor:
Information provided by (Responsible Party):
Fu Zhou Wang, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01184638
First received: August 16, 2010
Last updated: January 11, 2014
Last verified: January 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Fu Zhou Wang, Dr, 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: January 11, 2014
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
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on August 28, 2014