DeliriumNCT04505059
Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Patients Undergoing Cardiac Surgery
A study testing Precision cardiac anesthesia and Conventional cardiac anesthesia in people with Delirium and Condition, run by China National Center for Cardiovascular Diseases at 3 sites in China.
Trial summary
This is a prospective, multi-center, double-blind, randomized clinical trials. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Condition, Anesthesia
- What is being tested?
- Precision cardiac anesthesia and Conventional cardiac anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 3 sitesChina
- Study dates
- 11 Sep 2020to 18 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged≥18 years;
- ASA:I to III;
- Hemodynamic stability, LVEF≥40%;
- Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.
Who cannot join
- Declined to get involved;
- Emergency cases, heart transplantation;
- Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
- Previous history of drug and alcohol abuse,allergy to general anesthetics;
- Preoperative severe dementia, language barrier and mental illness
- Preoperative schizophrenia, epilepsy, stroke and Parkinson's disease
- Previous history of craniocerebral injury or neurosurgery;
- Any other conditions that are considered unsuitable for study participation.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
Beijing, 100037
Yuefu Wang, MD, +(86) 010-88396509, wangyuefu@hotmail.com
Chunrong Wang, MD, +(86) 010-88392469, Emancipation258@outlook.com
- Recruiting
The Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, 050000
Haitao Liu, MD, +(86)15130119853, mzlht@sina.com
- Recruiting
Tianjin Chest Hospital
Tianjin, 300222
Jiange Han, MD, +(86)022-88185152, hanjiange@163.com
About this study
Official title: Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery
This is a prospective, multi-center, double-blind, randomized clinical trials.
Read the 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.
- Conditions
- Delirium, Condition, Anesthesia
- Being tested
- Precision cardiac anesthesia, Conventional cardiac anesthesia
- Keywords
- Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia
- Medical subject headings
- Delirium, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Precision cardiac anesthesiaProcedure or surgery
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 or surgery
The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience
| Study group | Role | What they receive |
|---|---|---|
| Precision cardiac anesthesia | Experimental | Remifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation Receives: Procedure: Precision cardiac anesthesia |
| Conventional cardiac anesthesia | Active comparator | Institutional standard of care. Receives: Procedure: Conventional cardiac anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of postoperative delirium
Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
Measured: Postoperative day 1 to 5
Secondary outcomes (12)
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)
Measured: In hospital,up to 10 days, at 1,6 and 12 months after surgery
Ventilation time
Mechanical ventilation time after surgery
Measured: up to 1 month after surgery
Length of stay
Length of hospital and ICU stay
Measured: up to 2 months after surgery
Cost
health care costs of hospital and ICU
Measured: 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.
Measured: Postoperative day 1 to 5
Postoperative pain
Assessed by NRS (from 0 to 10, higher scores mean a worse outcome)
Measured: 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)
Measured: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
TNF-α
Inflammatory factor (TNF-α)
Measured: Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
IGF-1
Blood Biomarker (IGF-1)
Measured: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
CRP
Blood Biomarker (CRP)
Measured: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
S-100β protein
Blood Biomarker (S-100β protein)
Measured: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Genotype
Number of participants with target gene
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start11 Sep 2020
- Primary completion18 Jul 2022 (estimated)
- Study completion18 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 502 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Tianjin Chest Hospital, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Yuefu Wang, China National Center for Cardiovascular Diseases
- Investigators
- Yuefu Wang, MD, Study director, Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMCJiange Han, MD, Principal investigator, Tianjin Chest HospitalHaitao Liu, MD, Principal investigator, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505059
- Sponsor's protocol ID
- Precision-Delirium-Cognitive
- Status last verified
- Jan 2022
- First submitted
- 18 Jul 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Anesthetic Strategies on Postoperative Cognitive Function and Delirium in Adult Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04505059
- Acronym / sponsor ID
- Precision-Delirium-Cognitive
- Conditions
- Delirium, Condition, Anesthesia
- Keywords
- Postoperative cognitive function, Delirium, Cardiac Surgical Procedures, Precision cardiac anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 502 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Tianjin Chest Hospital, The Second Hospital of Hebei Medical University
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 18 Jul 2022 (estimated)
- Study completion
- 18 Jan 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precision cardiac anesthesia | Experimental | Procedure: Precision cardiac anesthesiaRemifentanil (TCI) for intra-operative analgesia Propofol (TCI) for intra-operative sedation |
| Conventional cardiac anesthesia | Active comparator | Procedure: Conventional cardiac anesthesiaInstitutional standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged≥18 years;
- ASA:I to III;
- Hemodynamic stability, LVEF≥40%;
- Cardiac surgery including CABG, valve surgery, CABG combined with valve surgery, surgical repair of ASD,VSD and atrial myxoma, and other types.
Key exclusion criteria (8 listed)
- Declined to get involved;
- Emergency cases, heart transplantation;
- Severe hepatic insufficiency (Child-Pugh grades C),Severe renal insufficiency (requirement of renal replacement therapy);
- Previous history of drug and alcohol abuse,allergy to general anesthetics;
- Preoperative severe dementia, language barrier and mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Precision cardiac anesthesiaAperi-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. | Procedure or surgery | Precision cardiac anesthesia |
| Conventional cardiac anesthesiaThe anesthesia strategy is mainly depending on the anesthesiologist's clinical experience | Procedure or surgery | Conventional cardiac anesthesia |
Primary outcome
Rate of postoperative delirium
Time frame: Postoperative day 1 to 5
Delirium assessed by using Confusion Assessment Method-ICU (CAM-ICU) in the postoperative period
12 secondary outcomes
Postoperative cognitive function
Time frame: In hospital,up to 10 days, at 1,6 and 12 months after surgery
Ventilation time
Time frame: up to 1 month after surgery
Length of stay
Time frame: up to 2 months after surgery
Cost
Time frame: up to 2 months after surgery
PONV
Time frame: Postoperative day 1 to 5
Postoperative pain
Time frame: Postoperative day 1 to 5, at 1,6 and 12 months after surgery
IL-6, IL-8, IL-10
Time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h,after surgery
TNF-α
Time frame: Before surgery, 6h, postoperative day 1(POD1 )morning, 24h after surgery
IGF-1
Time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
CRP
Time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
S-100β protein
Time frame: Before surgery, 6h, postoperative day 1 (POD1) morning, 24h after surgery
Genotype
Time frame: Before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuefu Wang, MD study director
Fuwai Hospital, China National Center for Cardiovascular Diseases, CAMS&PUMC
Jiange Han, MD principal investigator
Tianjin Chest Hospital
Haitao Liu, MD principal investigator
The Second Hospital of Hebei Medical University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Precision cardiac anesthesia and Conventional cardiac anesthesia in people with Delirium and Condition, run by China National Center for Cardiovascular Diseases at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuefu Wang, MD (+(86)010-88396509, wangyuefu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of postoperative delirium (time frame: Postoperative day 1 to 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.