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

China National Center for Cardiovascular Diseases502 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

502

Conditions

Delirium Condition Anesthesia

Interventions

Precision cardiac anesthesiaPROCEDURE

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 anesthesiaPROCEDURE

The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

The Second Hospital of HeBei Medical University

Shijiazhuang, Hebei, China

RECRUITING

Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC

Beijing, China

RECRUITING

Tianjin Chest Hospital

Tianjin, China

RECRUITING

Outcomes

Primary Outcomes

Rate of postoperative delirium

Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period

Time frame: Postoperative day 1 to 5

Secondary Outcomes

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)

Time frame: In hospital,up to 10 days, at 1,6 and 12 months after surgery

Ventilation time

Mechanical ventilation time after surgery

Time frame: up to 1 month after surgery

Length of stay

Length of hospital and ICU stay

Time frame: up to 2 months after surgery

Cost

health care costs of hospital and ICU

Time frame: 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.

Time frame: Postoperative day 1 to 5

Postoperative pain

Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)

Time frame: 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)

Central Contacts

Yuefu Wang, MD

CONTACT

+(86)010-88396509 wangyuefu@hotmail.com

Yuchen Gao, MD

CONTACT

+(86)010-88392469 gaoyuchen_pumc@hotmail.com

Data from ClinicalTrials.gov

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