Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery

February 28, 2022 updated by: Yuefu Wang, China National Center for Cardiovascular Diseases

Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery

This is a prospective, multi-center, double-blind, randomized clinical trials.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective randomized multi-center trial involving about 502 subjects will be enrolled in 3 centers. Patients will be randomized to two groups in equal proportion. Investigators set a hypothesis that precision cardiac anesthesia, which involves the modification of several crucial anesthetic modalities, would reduces the incidence of postoperative cognitive function and delirium in patients undergoing cardiac surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
502

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100037
        • Recruiting
        • Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuefu Wang, MD
      • Tianjin, China, 300222
        • Recruiting
        • Tianjin Chest Hospital
        • Contact:
    • Hebei
      • Shijia Zhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged≥18 years;
  2. ASA:I to III;
  3. Hemodynamic stability, LVEF≥40%;
  4. Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.

Exclusion Criteria:

  1. Declined to get involved;
  2. Emergency cases, heart transplantation;
  3. Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
  4. Previous history of drug and alcohol abuse,allergy to general anesthetics;
  5. Preoperative severe dementia, language barrier and mental illness
  6. Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease
  7. Previous history of craniocerebral injury or neurosurgery;
  8. Any other conditions that are considered unsuitable for study participation.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Precision cardiac anesthesia
Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation
Procedure: Precision cardiac anesthesia
Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.
Active Comparator: Conventional cardiac anesthesia
Institutional standard of care.
Procedure: Conventional cardiac anesthesia
The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of postoperative delirium
Time Frame: Postoperative day 1 to 5
Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
Postoperative day 1 to 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative cognitive function
Time Frame: In hospital,up to 10 days, at 1,6 and 12 months after surgery
Assessed by MoCA (score range from 0 to 30, higher scores mean a better outcome) or MMSE (score range from 0 to 30, higher scores mean a better outcome)
In hospital,up to 10 days, at 1,6 and 12 months after surgery
Ventilation time
Time Frame: up to 1 month after surgery
Mechanical ventilation time after surgery
up to 1 month after surgery
Length of stay
Time Frame: up to 2 months after surgery
Length of hospital and ICU stay
up to 2 months after surgery
Cost
Time Frame: up to 2 months after surgery
health care costs of hospital and ICU
up to 2 months after surgery
PONV
Time Frame: Postoperative day 1 to 5

To quantify postoperative nausea and vomiting the following score was used:

0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.
Postoperative day 1 to 5
Postoperative pain
Time Frame: Postoperative day 1 to 5, at 1,6 and 12 months after surgery
Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
Postoperative day 1 to 5, at 1,6 and 12 months after surgery
IL-6, IL-8, IL-10
Time Frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
Inflammatory factor (IL-6, IL-8, IL-10)
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
TNF-α
Time Frame: Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
Inflammatory factor (TNF-α)
Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
IGF-1
Time Frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Blood Biomarker (IGF-1)
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
CRP
Time Frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Blood Biomarker (CRP)
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
S-100β protein
Time Frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Blood Biomarker (S-100β protein)
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Genotype
Time Frame: Before surgery
Number of participants with target gene
Before surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of postoperative complications
Time Frame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
Postoperative main complications
In hospital,up to 10 days, at 1,3 and 12 months after surgery
Rate of mortality
Time Frame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
All-cause mortality
In hospital,up to 10 days, at 1,3 and 12 months after surgery
Patient's life quality
Time Frame: At 1,3 and 12 months after surgery
Quality of life was assessed by SF-36. A self-administered 36-item question- naire covering eight different domains: physical functioning, physical role functioning, bodily pain, general health, vitality, social functioning, emotional role functioning, and mental health. Raw points are transformed into a score from 0 to 100 for each dimension, with 100 reflecting the best possible health-related quality of life.
At 1,3 and 12 months after surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Second Hospital of Hebei Medical University
Tianjin Chest Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Yuefu Wang, MD, Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
  • Principal Investigator: Jiange Han, MD, Tianjin Chest Hospital
  • Principal Investigator: Haitao Liu, MD, The Second Hospital of Hebei 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 18, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 18, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 18, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Precision-Delirium-Cognitive

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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