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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

August 16, 2010
January 11, 2014
August 2010
August 2020   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01184638 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Long-term Outcome of General Anesthesia on Dysgnosia
Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Delirium,
  • Dementia,
  • Amnestic,
  • Cognitive Disorders
  • Drug: Sevoflurane
    1-8% sevoflurane for maintaining the whole period of general anesthesia
    Other Name: Sevorane
  • Drug: Propofol
    1-4 mg/kg/h of propofol during the whole period of general anesthesia
    Other Name: Diprivan
  • 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
    Intervention: Drug: Sevoflurane
  • Active Comparator: Intravenous anesthesia
    Patients received intravenous anesthetic (Propofol) during general anesthesia
    Intervention: Drug: Propofol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10000
August 2020
August 2020   (final data collection date for primary outcome measure)

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
Both
10 Years to 80 Years
No
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
China
 
NCT01184638
NJMU-2010-07022, NJFY7M12
Yes
Fu Zhou Wang, Nanjing Medical University
Nanjing Medical University
Not Provided
Study Director: FuZhou Wang, PhD MD Nanjing Medical University
Nanjing Medical University
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP