NCT04505059

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
502

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 18, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

March 15, 2022

Status Verified

January 1, 2022

Enrollment Period

1.8 years

First QC Date

July 18, 2020

Last Update Submit

February 28, 2022

Conditions

DeliriumConditionAnesthesia

Keywords

Postoperative cognitive functionDeliriumCardiac Surgical ProceduresPrecision cardiac anesthesia

Outcome Measures

Primary Outcomes (1)

  • Rate of postoperative delirium

    Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period

    Postoperative day 1 to 5

Secondary Outcomes (12)

  • Postoperative cognitive function

    In hospital,up to 10 days, at 1,6 and 12 months after surgery

  • Ventilation time

    up to 1 month after surgery

  • Length of stay

    up to 2 months after surgery

  • Cost

    up to 2 months after surgery

  • PONV

    Postoperative day 1 to 5

  • +7 more secondary outcomes

Other Outcomes (3)

  • Rate of postoperative complications

    In hospital,up to 10 days, at 1,3 and 12 months after surgery

  • Rate of mortality

    In hospital,up to 10 days, at 1,3 and 12 months after surgery

  • Patient's life quality

    At 1,3 and 12 months after surgery

Study Arms (2)

Precision cardiac anesthesia

EXPERIMENTAL

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

Procedure: Precision cardiac anesthesia

Conventional cardiac anesthesia

ACTIVE COMPARATOR

Institutional standard of care.

Procedure: Conventional cardiac anesthesia

Interventions

Precision cardiac anesthesiaPROCEDURE

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.

Precision cardiac anesthesia
Conventional cardiac anesthesiaPROCEDURE

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

Conventional cardiac anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, 050000, China

RECRUITING

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

Beijing, 100037, China

RECRUITING

Tianjin Chest Hospital

Tianjin, 300222, China

RECRUITING

MeSH Terms

Conditions

DeliriumDisease

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic Processes

Study Officials

  • Yuefu Wang, MD

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

    STUDY DIRECTOR

  • Jiange Han, MD

    Tianjin Chest Hospital

    PRINCIPAL INVESTIGATOR

  • Haitao Liu, MD

    The Second Hospital of Hebei Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuefu Wang, MD

CONTACT

+(86)010-88396509wangyuefu@hotmail.com

Yuchen Gao, MD

CONTACT

+(86)010-88392469gaoyuchen_pumc@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2020

First Posted

August 7, 2020

Study Start

September 11, 2020

Primary Completion

July 18, 2022

Study Completion

January 18, 2023

Last Updated

March 15, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)