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

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: Recruiting
• Conditions: Delirium; Anesthesia; Condition
• Intervention / Treatment: Procedure: Precision cardiac anesthesia; Procedure: Conventional cardiac anesthesia

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: Interventional
• Enrollment (Anticipated): 502
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuefu Wang, MD; Phone Number: +(86)010-88396509; Email: wangyuefu@hotmail.com
• Study Contact Backup: Name: Yuchen Gao, MD; Phone Number: +(86)010-88392469; Email: gaoyuchen_pumc@hotmail.com

Study Locations

• China
  • Beijing, China, 100037
    • Recruiting
    • Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
    • Contact: Yuefu Wang, MD; Phone Number: +(86) 010-88396509; Email: wangyuefu@hotmail.com
    • Contact: Chunrong Wang, MD; Phone Number: +(86) 010-88392469; Email: Emancipation258@outlook.com
    • Principal Investigator: Yuefu Wang, MD
  • Tianjin, China, 300222
    • Recruiting
    • Tianjin Chest Hospital
    • Contact: Jiange Han, MD; Phone Number: +(86)022-88185152; Email: hanjiange@163.com
  • Hebei
    • Shijia Zhuang, Hebei, China, 050000
      • Recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Haitao Liu, MD; Phone Number: +(86)15130119853; Email: mzlht@sina.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Rate of postoperative delirium	Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period	Postoperative day 1 to 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	In hospital,up to 10 days, at 1,6 and 12 months after surgery
Ventilation time	Mechanical ventilation time after surgery	up to 1 month after surgery
Length of stay	Length of hospital and ICU stay	up to 2 months after surgery
Cost	health care costs of hospital and ICU	up to 2 months after surgery
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 day 1 to 5
Postoperative pain	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	Inflammatory factor (IL-6, IL-8, IL-10)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
TNF-α	Inflammatory factor (TNF-α)	Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
IGF-1	Blood Biomarker (IGF-1)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
CRP	Blood Biomarker (CRP)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
S-100β protein	Blood Biomarker (S-100β protein)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Genotype	Number of participants with target gene	Before surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of postoperative complications	Postoperative main complications	In hospital,up to 10 days, at 1,3 and 12 months after surgery
Rate of mortality	All-cause mortality	In hospital,up to 10 days, at 1,3 and 12 months after surgery
Patient's life quality	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

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: The Second Hospital of Hebei Medical University; Tianjin Chest Hospital
• Investigators: 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

Study Major Dates

• Study Start (Actual): September 11, 2020
• Primary Completion (Anticipated): July 18, 2022
• Study Completion (Anticipated): January 18, 2023

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Delirium; Cardiac Surgical Procedures; Postoperative cognitive function; Precision cardiac anesthesia
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID 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