Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With MCI
MCI
The Appropriate Compatibility of Propofol and Sevoflurane for Orthopaedic Surgery of Patients With Mild Cognitive Impairment
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 10, 2016
CompletedFirst Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2018
CompletedMay 25, 2018
May 1, 2017
1.7 years
May 17, 2017
May 23, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ）
Measurement by ELISA kit
Change from Baseline Apolipoprotein J at 7 days
Secondary Outcomes (3)
Evidence of clinically cognitive function decline ：Soluble CD14（sCD14）
Change from Baseline Soluble CD14 at 7 days
Mini mental Examination(MMSE)
preoperative 24 hours ， 7 days post surgery
Montreal Cognitive Assessment（MoCA)
preoperative 24 hours ，7 days post surgery
Study Arms (4)
Propofol
EXPERIMENTALadministrated Target Controlled Infusion （TCI）of propofol （Cp 2.0\~2.5μg/ml ）for maintaining
1.2 μg/ml Propofol
EXPERIMENTALadministrated Target Controlled Infusion （TCI）of propofol （Cp 1.2 μg/ml ）combined with appropriate sevoflurane for maintaining
0.6 μg/ml Propofol
EXPERIMENTALadministrated Target Controlled Infusion （TCI）of propofol （Cp 0.6 μg/ml ）combined with appropriate sevoflurane for maintaining
Sevoflurane
EXPERIMENTALadministrated 1.3 minimum alveolar concentration（MAC ） sevoflurane for maintaining
Interventions
Propofol is the most common clinical anesthetics.
Sevoflurane is the most common clinical anesthetics.
Eligibility Criteria
You may qualify if:
- Elective orthopaedic surgery
- American Society of Anesthesiologists physical status: II
You may not qualify if:
- Neurological diseases that may affect cognitive function (e.g., subdural hematoma)
- Hypothyroidism
- Alcoholic dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Third Central Hospital of Tianjin
Tianjin, Tianjin Municipality, 022, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 24, 2017
Study Start
November 10, 2016
Primary Completion
August 1, 2018
Study Completion
November 1, 2018
Last Updated
May 25, 2018
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share