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

Primary Purpose

Cognitive Impairment, Mild

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
The Third Central Clinical College of Tianjin Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment, Mild focused on measuring mild cognitive impairment

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Third Central Hospital of TianjinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Propofol

1.2 μg/ml Propofol

0.6 μg/ml Propofol

Sevoflurane

Arm Description

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

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

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

administrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining

Outcomes

Primary Outcome Measures

Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Measurement by ELISA kit

Secondary Outcome Measures

Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Estimating by ELISA kit
Mini mental Examination(MMSE)
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
Montreal Cognitive Assessment（MoCA)
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.

Full Information

First Posted
May 17, 2017
Last Updated
May 23, 2018
Sponsor
The Third Central Clinical College of Tianjin Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03165396
Brief Title
Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI
Acronym
MCI
Official Title
The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 10, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Third Central Clinical College of Tianjin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Mild
Keywords
mild cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Propofol
Arm Type
Experimental
Arm Description
administrated Target Controlled Infusion （TCI）of propofol （Cp 2.0~2.5μg/ml ）for maintaining
Arm Title
1.2 μg/ml Propofol
Arm Type
Experimental
Arm Description
administrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining
Arm Title
0.6 μg/ml Propofol
Arm Type
Experimental
Arm Description
administrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining
Arm Title
Sevoflurane
Arm Type
Experimental
Arm Description
administrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Propofol is the most common clinical anesthetics.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane is the most common clinical anesthetics.
Primary Outcome Measure Information:
Title
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Description
Measurement by ELISA kit
Time Frame
Change from Baseline Apolipoprotein J at 7 days
Secondary Outcome Measure Information:
Title
Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Description
Estimating by ELISA kit
Time Frame
Change from Baseline Soluble CD14 at 7 days
Title
Mini mental Examination(MMSE)
Description
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
Time Frame
preoperative 24 hours ， 7 days post surgery
Title
Montreal Cognitive Assessment（MoCA)
Description
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.
Time Frame
preoperative 24 hours ，7 days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyun Wang
Phone
86-13752211206
Email
why@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yimeng Chen
Email
chenyimeng5525@163.com
Facility Information:
Facility Name
Third Central Hospital of Tianjin
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haiyun Wang
Email
why819@126.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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