NCT01184638

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

August 16, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

10 years

First QC Date

August 16, 2010

Last Update Submit

January 11, 2014

Conditions

Delirium,Dementia,Amnestic,Cognitive Disorders

Keywords

Cognitive DisordersGeneral anesthesiaSevofluranePropofolMemory

Outcome Measures

Primary Outcomes (1)

  • Cognitive ability

    Cognitive ability will be assessed with digital lignature game, figure identificaiton, and recall memory

    The 10th year since postoperation

Secondary Outcomes (6)

  • Cognitive ability

    One hour before operation

  • Cognitive ability

    Immediately after operation (0 day)

  • Cognitive ability

    One month after operation

  • Cognitive ability

    Six month after operation

  • Cognitive ability

    One year after operation

  • +1 more secondary outcomes

Study Arms (3)

Local anesthesia

NO INTERVENTION

Patients received local anesthesia without any intervention of general anesthetics

Inhalational anesthesia

ACTIVE COMPARATOR

Patients received sevoflurane anesthesia during general anesthesia

Drug: Sevoflurane

Intravenous anesthesia

ACTIVE COMPARATOR

Patients received intravenous anesthetic (Propofol) during general anesthesia

Drug: Propofol

Interventions

SevofluraneDRUG

1-8% sevoflurane for maintaining the whole period of general anesthesia

Also known as: Sevorane
Inhalational anesthesia
PropofolDRUG

1-4 mg/kg/h of propofol during the whole period of general anesthesia

Also known as: Diprivan
Intravenous anesthesia

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with informed consents
  • Without basal disorders of neurology and psychiatrics

You may not qualify if:

  • With the history of cognitive disorders
  • With chronic neurological disorders
  • Cannot communicate with investigators
  • Cannot stand general anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, 210004, China

RECRUITING

MeSH Terms

Conditions

DeliriumDementiaCognitive Dysfunction

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition Disorders

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • FuZhou Wang, PhD MD

    Nanjing Medical University

    STUDY DIRECTOR

Central Study Contacts

FuZhou Wang, PhD MD

CONTACT

86 25 84460777zfwang50@gmail.com

XiaoFeng Shen, MPH, MD

CONTACT

86 25 84460777sxf0418@njmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 16, 2010

First Posted

August 19, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

January 14, 2014

Record last verified: 2014-01

Locations

CN(1)