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

China National Center for Cardiovascular Diseases3 sites in 1 country502 target enrollmentSeptember 11, 2020

ConditionsDelirium Condition Anesthesia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Delirium
Sponsor: China National Center for Cardiovascular Diseases
Enrollment: 502
Locations: 3
Primary Endpoint: Rate of postoperative delirium
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 11, 2020

End Date

January 18, 2023

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

China National Center for Cardiovascular Diseases

Responsible Party

Principal Investigator

Yuefu Wang

Professor

China National Center for Cardiovascular Diseases

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

Length of stay(up to 2 months after surgery)
S-100β protein(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
Postoperative pain(Postoperative day 1 to 5, at 1,6 and 12 months after surgery)
IGF-1(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
Cost(up to 2 months after surgery)
Postoperative cognitive function(In hospital,up to 10 days, at 1,6 and 12 months after surgery)
TNF-α(Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery)
CRP(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery)
Genotype(Before surgery)
Ventilation time(up to 1 month after surgery)
PONV(Postoperative day 1 to 5)
IL-6, IL-8, IL-10(Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery)