Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04505059
Other study ID # Precision-Delirium-Cognitive
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04580030 - Tricuapid Annular Plane Sistolic Excursion Before General Anesthesia Can Predict Hypotension After Induction
Active, not recruiting NCT04279054 - Decreased Neuraxial Morphine After Cesarean Delivery Early Phase 1
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Recruiting NCT04099693 - A Prospective Randomized Study of General Anesthesia Versus Anesthetist Administered Sedation for ERCP
Terminated NCT02481999 - Pre- and Postoperative EEG-Monitoring for Children Aged From 0,5 to 8 Years
Completed NCT04235894 - An Observer Rating Scale of Facial Expression Can Predict Dreaming in Propofol Anesthesia
Recruiting NCT05525104 - The Effect of DSA on Recovery of Anaesthesia in Children (Het Effect Van DSA op Het Herstel na Anesthesie Bij Kinderen). N/A
Recruiting NCT05024084 - Desflurane and Sevoflurane Minimal Flow Anesthesia on Recovery and Anesthetic Depth Phase 4
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03277872 - NoL, HR and MABP Responses to Tracheal Intubation Performed With MAC Blade Versus Glidescope N/A
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Terminated NCT02529696 - Measuring Sedation in the Intensive Care Unit Using Wireless Accelerometers
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Terminated NCT03704285 - Development of pk/pd Model of Propofol in Patients With Severe Burns
Recruiting NCT05259787 - EP Intravenous Anesthesia in Hysteroscopy Phase 4
Completed NCT02894996 - Does the Response to a Mini-fluid Challenge of 3ml/kg in 2 Minutes Predict Fluid Responsiveness for Pediatric Patient? N/A
Completed NCT05386082 - Anesthesia Core Quality Metrics Consensus Delphi Study
Terminated NCT03567928 - Laryngeal Mask in Upper Gastrointestinal Procedures N/A
Recruiting NCT06074471 - Motor Sparing Supraclavicular Block N/A
Completed NCT04163848 - CARbon Impact of aNesthesic Gas