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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505059
• Other study ID #: Precision-Delirium-Cognitive
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2020
• Est. completion date: January 18, 2023

Study information

• Verified date: January 2022
• Source: China National Center for Cardiovascular Diseases
• Contact: Yuefu Wang, MD
• Phone: +(86)010-88396509
• Email: wangyuefu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: January 18, 2023
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Condition
• Delirium

Intervention

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.
• Conventional cardiac anesthesia
The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience

Locations

Country	Name	City	State
China	Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC	Beijing
China	The Second Hospital of HeBei Medical University	Shijia Zhuang	Hebei
China	Tianjin Chest Hospital	Tianjin

Sponsors (3)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	The Second Hospital of Hebei Medical University, Tianjin Chest Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of postoperative complications	Postoperative main complications	In hospital,up to 10 days, at 1,3 and 12 months after surgery
Other	Rate of mortality	All-cause mortality	In hospital,up to 10 days, at 1,3 and 12 months after surgery
Other	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
Primary	Rate of postoperative delirium	Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period	Postoperative day 1 to 5
Secondary	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
Secondary	Ventilation time	Mechanical ventilation time after surgery	up to 1 month after surgery
Secondary	Length of stay	Length of hospital and ICU stay	up to 2 months after surgery
Secondary	Cost	health care costs of hospital and ICU	up to 2 months after surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	TNF-a	Inflammatory factor (TNF-a)	Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
Secondary	IGF-1	Blood Biomarker (IGF-1)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Secondary	CRP	Blood Biomarker (CRP)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Secondary	S-100ß protein	Blood Biomarker (S-100ß protein)	Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Secondary	Genotype	Number of participants with target gene	Before surgery