Long-term Outcome of General Anesthesia on Dysgnosia

NCT ID: NCT01184638

Last Updated: 2014-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

10000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2020-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Delirium, Dementia, Amnestic, Cognitive Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Local anesthesia

Patients received local anesthesia without any intervention of general anesthetics

Group Type NO_INTERVENTION

No interventions assigned to this group

Inhalational anesthesia

Patients received sevoflurane anesthesia during general anesthesia

Group Type ACTIVE_COMPARATOR

Sevoflurane

Intervention Type DRUG

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

Intravenous anesthesia

Patients received intravenous anesthetic (Propofol) during general anesthesia

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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

Interventions

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Sevoflurane

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

Intervention Type DRUG

Propofol

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

Intervention Type DRUG

Other Intervention Names

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Sevorane Diprivan

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Fu Zhou Wang

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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FuZhou Wang, PhD MD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

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Nanjing Maternity and Child Health Care Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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FuZhou Wang, PhD MD

Role: CONTACT

86 25 84460777 ext. 3301

XiaoFeng Shen, MPH, MD

Role: CONTACT

86 25 84460777 ext. 3303

Facility Contacts

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YuZhu Peng, MD

Role: primary

86 25 84460777 ext. 1508

XiRong Guo, MD

Role: backup

86 25 84460777 ext. 1508

Other Identifiers

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NJFY7M12

Identifier Type: -

Identifier Source: secondary_id

NJMU-2010-07022

Identifier Type: -

Identifier Source: org_study_id

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