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

Sponsor

The Third Central Clinical College of Tianjin Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03165396

Collaborator

(none)

100

Enrollment

Location

Arms

23.7

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Impairment, Mild	Drug: Propofol Drug: Sevoflurane	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 10, 2016

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Nov 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

Evidence of clinically cognitive function decline ：Apolipoprotein J（ApoJ） [Change from Baseline Apolipoprotein J at 7 days]
Measurement by ELISA kit

Secondary Outcome Measures

Evidence of clinically cognitive function decline ：Soluble CD14（sCD14） [Change from Baseline Soluble CD14 at 7 days]
Estimating by ELISA kit
Mini mental Examination(MMSE) [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
Montreal Cognitive Assessment（MoCA) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Third Central Hospital of Tianjin	Tianjin	Tianjin	China	022

Sponsors and Collaborators

The Third Central Clinical College of Tianjin Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Third Central Clinical College of Tianjin Medical University

ClinicalTrials.gov Identifier:

NCT03165396

Other Study ID Numbers:

szxlcyj-chen

First Posted:

May 24, 2017

Last Update Posted:

May 25, 2018

Last Verified:

May 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by The Third Central Clinical College of Tianjin Medical University

mild cognitive impairment

Additional relevant MeSH terms:

Cognitive Dysfunction

Propofol

Sevoflurane

Study Results

No Results Posted as of May 25, 2018