Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI

NCT ID: NCT03165396

Last Updated: 2018-05-25

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

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-10

Study Completion Date

2018-11-01

Brief Summary

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According to the inclusion and exclusion criteria, elderly patients undergoing elective orthopedic surgery were randomly divided into four groups. The different combinations of propofol and sevoflurane were used in the four groups: 1 day before surgery, after patients become wide-awake, and 3 days, 7 days, and 3 months after surgery, the patient's cognitive function was evaluated using a professional cognitive scale and other indicators. Finally, statistical analysis.

Detailed Description

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Conditions

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Cognitive Impairment, Mild

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Propofol

administrated Target Controlled Infusion (TCI)of propofol (Cp 2.0\~2.5μg/ml )for maintaining

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol is the most common clinical anesthetics.

1.2 μg/ml Propofol

administrated Target Controlled Infusion (TCI)of propofol (Cp 1.2 μg/ml )combined with appropriate sevoflurane for maintaining

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol is the most common clinical anesthetics.

Sevoflurane

Intervention Type DRUG

Sevoflurane is the most common clinical anesthetics.

0.6 μg/ml Propofol

administrated Target Controlled Infusion (TCI)of propofol (Cp 0.6 μg/ml )combined with appropriate sevoflurane for maintaining

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Propofol is the most common clinical anesthetics.

Sevoflurane

Intervention Type DRUG

Sevoflurane is the most common clinical anesthetics.

Sevoflurane

administrated 1.3 minimum alveolar concentration(MAC ) sevoflurane for maintaining

Group Type EXPERIMENTAL

Sevoflurane

Intervention Type DRUG

Sevoflurane is the most common clinical anesthetics.

Interventions

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Propofol

Propofol is the most common clinical anesthetics.

Intervention Type DRUG

Sevoflurane

Sevoflurane is the most common clinical anesthetics.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective orthopaedic surgery
* American Society of Anesthesiologists physical status: II

Exclusion Criteria

* Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
* Hypothyroidism
* Alcoholic dementia
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Third Central Clinical College of Tianjin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Third Central Hospital of Tianjin

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Haiyun Wang

Role: CONTACT

86-13752211206

Yimeng Chen

Role: CONTACT

Facility Contacts

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Haiyun Wang

Role: primary

Other Identifiers

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szxlcyj-chen

Identifier Type: -

Identifier Source: org_study_id

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