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

Not Applicable

• Conditions: Condition; Anesthesia; Delirium

• Registration Number: NCT04505059
• Lead Sponsor: China National Center for Cardiovascular Diseases

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.

Study Timeline

• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Study Start: 2020-09-11
• Status Verified: 2022-01
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-07-18
• Study Completion: 2023-01-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 502

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Length of stay	up to 2 months after surgery	Length of hospital and ICU stay
S-100β protein	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery	Blood Biomarker (S-100β protein)
Postoperative pain	Postoperative day 1 to 5, at 1,6 and 12 months after surgery	Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
Postoperative cognitive function	In hospital,up to 10 days, at 1,6 and 12 months after surgery	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)
TNF-α	Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery	Inflammatory factor (TNF-α)
CRP	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery	Blood Biomarker (CRP)
Genotype	Before surgery	Number of participants with target gene
Ventilation time	up to 1 month after surgery	Mechanical ventilation time after surgery
PONV	Postoperative day 1 to 5	To quantify postoperative nausea and vomiting the following score was used: 0 = no nausea, 1 = nausea, 2 = retching, 3 = single vomiting, 4 = multiple vomiting.
IL-6, IL-8, IL-10	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery	Inflammatory factor (IL-6, IL-8, IL-10)
IGF-1	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery	Blood Biomarker (IGF-1)
Cost	up to 2 months after surgery	health care costs of hospital and ICU

Trial Locations

Locations (3)

The Second Hospital of HeBei Medical University; 🇨🇳 Shijia Zhuang, Hebei, China

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC; 🇨🇳 Beijing, China

Tianjin Chest Hospital; 🇨🇳 Tianjin, China