Clinical trial NCT04505059: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium
Condition
Anesthesia
Keywords: Postoperative cognitive function
Delirium
Cardiac Surgical Procedures
Precision cardiac anesthesia
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Tianjin Chest Hospital
name: The Second Hospital of Hebei Medical University
First posted: 2020-08-07
Enrollment: 502
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of postoperative delirium
timeFrame: Postoperative day 1 to 5
Secondary outcomes:
measure: Postoperative cognitive function
timeFrame: In hospital,up to 10 days, at 1,6 and 12 months after surgery
measure: Ventilation time
timeFrame: up to 1 month after surgery
measure: Length of stay
timeFrame: up to 2 months after surgery
measure: Cost
timeFrame: up to 2 months after surgery
measure: PONV
timeFrame: Postoperative day 1 to 5
measure: Postoperative pain
timeFrame: Postoperative day 1 to 5, at 1,6 and 12 months after surgery
measure: IL-6, IL-8, IL-10
timeFrame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
measure: TNF-α
timeFrame: Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
measure: IGF-1
timeFrame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
measure: CRP
timeFrame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
measure: S-100β protein
timeFrame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
measure: Genotype
timeFrame: Before surgery
Other outcomes:
measure: Rate of postoperative complications
timeFrame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
measure: Rate of mortality
timeFrame: In hospital,up to 10 days, at 1,3 and 12 months after surgery
measure: Patient's life quality
timeFrame: At 1,3 and 12 months after surgery
Locations:
city: Shijia Zhuang
country: China
facility: The Second Hospital of HeBei Medical University
state: Hebei
city: Beijing
country: China
facility: Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
city: Tianjin
country: China
facility: Tianjin Chest Hospital
Study officials:
affiliation: Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
name: Yuefu Wang, MD
role: STUDY_DIRECTOR
affiliation: Tianjin Chest Hospital
name: Jiange Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Hebei Medical University
name: Haitao Liu, MD
role: PRINCIPAL_INVESTIGATOR
References: