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

NCT ID: NCT04505059

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

502 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-11

Study Completion Date

2023-01-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Delirium Condition Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Precision cardiac anesthesia

Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation

Group Type EXPERIMENTAL

Precision cardiac anesthesia

Intervention Type PROCEDURE

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.

Conventional cardiac anesthesia

Institutional standard of care.

Group Type ACTIVE_COMPARATOR

Conventional cardiac anesthesia

Intervention Type PROCEDURE

The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience

Interventions

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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.

Intervention Type PROCEDURE

Conventional cardiac anesthesia

The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Chest Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yuefu Wang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yuefu Wang, MD

Role: STUDY_DIRECTOR

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC

Jiange Han, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Chest Hospital

Haitao Liu, MD

Role: PRINCIPAL_INVESTIGATOR

The Second Hospital of Hebei Medical University

Locations

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The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC

Beijing, , China

Site Status RECRUITING

Tianjin Chest Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuefu Wang, MD

Role: CONTACT

+(86)010-88396509

Yuchen Gao, MD

Role: CONTACT

+(86)010-88392469

Facility Contacts

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Haitao Liu, MD

Role: primary

+(86)15130119853

Yuefu Wang, MD

Role: primary

+(86) 010-88396509

Chunrong Wang, MD

Role: backup

+(86) 010-88392469

Jiange Han, MD

Role: primary

+(86)022-88185152

Other Identifiers

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Precision-Delirium-Cognitive

Identifier Type: -

Identifier Source: org_study_id

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