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

May 23, 2018 updated by: The Third Central Clinical College of Tianjin Medical University

The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

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
    • Tianjin
      • Tianjin, Tianjin, China, 022
        • Recruiting
        • Third Central Hospital of Tianjin
        • Contact:

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
administrated Target Controlled Infusion （TCI）of propofol （Cp 2.0~2.5μg/ml ）for maintaining
Drug: Propofol
Propofol is the most common clinical anesthetics.
Experimental: 1.2 μg/ml Propofol
administrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining
Drug: Propofol
Propofol is the most common clinical anesthetics.
Drug: Sevoflurane
Sevoflurane is the most common clinical anesthetics.
Experimental: 0.6 μg/ml Propofol
administrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining
Drug: Propofol
Propofol is the most common clinical anesthetics.
Drug: Sevoflurane
Sevoflurane is the most common clinical anesthetics.
Experimental: Sevoflurane
administrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining
Drug: Sevoflurane
Sevoflurane is the most common clinical anesthetics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Time Frame: Change from Baseline Apolipoprotein J at 7 days
Measurement by ELISA kit
Change from Baseline Apolipoprotein J at 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Time Frame: Change from Baseline Soluble CD14 at 7 days
Estimating by ELISA kit
Change from Baseline Soluble CD14 at 7 days
Mini mental Examination(MMSE)
Time Frame: preoperative 24 hours ， 7 days post surgery
A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30，≦27 were considered as cognitive function decline
preoperative 24 hours ， 7 days post surgery
Montreal Cognitive Assessment（MoCA)
Time Frame: preoperative 24 hours ，7 days post surgery
A questionnaires is used to assess the cognitive function of patients in clinical.Total range was 0~30，≦27 were considered as cognitive function decline.
preoperative 24 hours ，7 days post surgery

Collaborators and Investigators

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

Sponsor

The Third Central Clinical College of Tianjin 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 (Actual)

November 10, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

May 17, 2017

First Submitted That Met QC Criteria

May 23, 2017

First Posted (Actual)

May 24, 2017

Study Record Updates

Last Update Posted (Actual)

May 25, 2018

Last Update Submitted That Met QC Criteria

May 23, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • szxlcyj-chen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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