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

Primary Purpose

Delirium, Condition, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Precision cardiac anesthesia
Conventional cardiac anesthesia
Sponsored by
China National Center for Cardiovascular Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Delirium focused on measuring Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Second Hospital of HeBei Medical UniversityRecruiting
  • Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMCRecruiting
  • Tianjin Chest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Precision cardiac anesthesia

Conventional cardiac anesthesia

Arm Description

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

Institutional standard of care.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative cognitive function
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)
Ventilation time
Mechanical ventilation time after surgery
Length of stay
Length of hospital and ICU stay
Cost
health care costs of hospital and ICU
PONV
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 pain
Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
IL-6, IL-8, IL-10
Inflammatory factor (IL-6, IL-8, IL-10)
TNF-α
Inflammatory factor (TNF-α)
IGF-1
Blood Biomarker (IGF-1)
CRP
Blood Biomarker (CRP)
S-100β protein
Blood Biomarker (S-100β protein)
Genotype
Number of participants with target gene

Full Information

First Posted
July 18, 2020
Last Updated
February 28, 2022
Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Tianjin Chest Hospital, The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04505059
Brief Title
Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery
Official Title
Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2020 (Actual)
Primary Completion Date
July 18, 2022 (Anticipated)
Study Completion Date
January 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China National Center for Cardiovascular Diseases
Collaborators
Tianjin Chest Hospital, The Second Hospital of Hebei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Condition, Anesthesia
Keywords
Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
502 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Precision cardiac anesthesia
Arm Type
Experimental
Arm Description
Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation
Arm Title
Conventional cardiac anesthesia
Arm Type
Active Comparator
Arm Description
Institutional standard of care.
Intervention Type
Procedure
Intervention Name(s)
Precision cardiac anesthesia
Intervention Description
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
Intervention Name(s)
Conventional cardiac anesthesia
Intervention Description
The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience
Primary Outcome Measure Information:
Title
Rate of postoperative delirium
Description
Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
Time Frame
Postoperative day 1 to 5
Secondary Outcome Measure Information:
Title
Postoperative cognitive function
Description
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)
Time Frame
In hospital,up to 10 days, at 1,6 and 12 months after surgery
Title
Ventilation time
Description
Mechanical ventilation time after surgery
Time Frame
up to 1 month after surgery
Title
Length of stay
Description
Length of hospital and ICU stay
Time Frame
up to 2 months after surgery
Title
Cost
Description
health care costs of hospital and ICU
Time Frame
up to 2 months after surgery
Title
PONV
Description
To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.
Time Frame
Postoperative day 1 to 5
Title
Postoperative pain
Description
Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
Time Frame
Postoperative day 1 to 5, at 1,6 and 12 months after surgery
Title
IL-6, IL-8, IL-10
Description
Inflammatory factor (IL-6, IL-8, IL-10)
Time Frame
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
Title
TNF-α
Description
Inflammatory factor (TNF-α)
Time Frame
Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
Title
IGF-1
Description
Blood Biomarker (IGF-1)
Time Frame
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Title
CRP
Description
Blood Biomarker (CRP)
Time Frame
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Title
S-100β protein
Description
Blood Biomarker (S-100β protein)
Time Frame
Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Title
Genotype
Description
Number of participants with target gene
Time Frame
Before surgery
Other Pre-specified Outcome Measures:
Title
Rate of postoperative complications
Description
Postoperative main complications
Time Frame
In hospital,up to 10 days, at 1,3 and 12 months after surgery
Title
Rate of mortality
Description
All-cause mortality
Time Frame
In hospital,up to 10 days, at 1,3 and 12 months after surgery
Title
Patient's life quality
Description
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.
Time Frame
At 1,3 and 12 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuefu Wang, MD
Phone
+(86)010-88396509
Email
wangyuefu@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuchen Gao, MD
Phone
+(86)010-88392469
Email
gaoyuchen_pumc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuefu Wang, MD
Organizational Affiliation
Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jiange Han, MD
Organizational Affiliation
Tianjin Chest Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Haitao Liu, MD
Organizational Affiliation
The Second Hospital of Hebei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of HeBei Medical University
City
Shijia Zhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haitao Liu, MD
Phone
+(86)15130119853
Email
mzlht@sina.com
Facility Name
Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
City
Beijing
ZIP/Postal Code
100037
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuefu Wang, MD
Phone
+(86) 010-88396509
Email
wangyuefu@hotmail.com
First Name & Middle Initial & Last Name & Degree
Chunrong Wang, MD
Phone
+(86) 010-88392469
Email
Emancipation258@outlook.com
First Name & Middle Initial & Last Name & Degree
Yuefu Wang, MD
Facility Name
Tianjin Chest Hospital
City
Tianjin
ZIP/Postal Code
300222
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiange Han, MD
Phone
+(86)022-88185152
Email
hanjiange@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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