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

January 11, 2014 updated by: Fu Zhou Wang, Nanjing Medical University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210004
        • Recruiting
        • Nanjing Maternity and Child Health Care Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • ShiQin Xu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Diprivan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive ability
Time Frame: The 10th year since postoperation
Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory
The 10th year since postoperation

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Medical University

Investigators

  • Study Director: FuZhou Wang, PhD MD, Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

August 1, 2020

Study Registration Dates

First Submitted

August 16, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (ESTIMATE)

August 19, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 11, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJMU-2010-07022
  • NJFY7M12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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