Intensive Care UnitNCT04906915
Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery
A study testing Ketamine in people with Intensive Care Unit, run by First People's Hospital of Chenzhou at 1 site in China.
Trial summary
After cardiopulmonary bypass heart surgery, with the rewarming of body temperature, the metabolic capacity of the body is enhanced, the microcirculation is opened, and tissue perfusion is increased. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit
- What is being tested?
- Ketamine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 8 May 2021to May 2022
- 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
- Consecutive adult (>18years)patients after heart surgery
Who cannot join
- Chronic kidney disease (CKD); ECMO or IABP assistance is required; Malignant tumor; Acquired immunodeficiency syndrome; receive psychiatric medication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Hospital Chenzhou
Chenzhou, Hunan, 450003
Xingui XG Dai, MD, 18175708210
About this study
After cardiopulmonary bypass heart surgery, with the rewarming of body temperature, the metabolic capacity of the body is enhanced, the microcirculation is opened, and tissue perfusion is increased. At the same time, the body pays off the oxygen debt formed by the low temperature and reduced blood flow in cardiopulmonary bypass, so that the tissue oxygen demand increases and oxygen consumption increases.Analgesia and sedation are important treatment measures for patients after cardiopulmonary bypass. S-isomer of ketamine and eselamine enhanced the sedation and enhanced the analgesic effect, but whether it can improve the imbalance of oxygen supply and oxygen consumption after cardiopulmonary bypass is unknown.
Read the detailed description
After cardiopulmonary bypass, the body usually appears in a state of hypermetabolism. In addition to anesthesia resuscitation and recovery of spontaneous respiration, chills, pain and anxiety can increase oxygen demand, increased oxygen consumption is also related to a series of neuroendocrine reactions.At the same time, the body needs to repay the oxygen debt formed by low temperature and reduced blood flow in extracorporeal circulation, so that the tissue oxygen demand increases, and the systemic oxygen consumption is significantly higher than the normal physiological state.
Sedation and analgesia treatment is one of the important early treatment measures for patients after heart surgery. Patients with heart disease are prone to anxiety and restlessness due to reduced cardiac function reserve, severe surgical trauma and extracorporeal circulation, which can lead to hemodilution, tissue edema, ischemia and reperfusion injury, etc. In addition, patients with high preoperative mental stress are prone to anxiety and restlessness.Appropriate sedation and analgesia treatment is very important to reduce stress response, reduce oxygen consumption and maintain the stability of hemodynamics.
The application of ketamine in sedation and analgesia has the characteristics of high controllability, and it does not inhibit respiration and mildly excites circulation, but whether it can improve the imbalance of oxygen supply and demand in patients after cardiopulmonary bypass is unknown.Therefore, it is of great significance to investigate the effect of ketamine on oxygen supply and oxygen consumption of patients after cardiopulmonary bypass surgery.
- Conditions
- Intensive Care Unit
- Being tested
- Ketamine
- Keywords
- Ketamine, Extracorporeal circulation, Oxygen Supply, Oxygen Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
The efficacy of ketamine was assessed by calculating oxygen supply and consumption
| Study group | Role | What they receive |
|---|---|---|
| Ketamine | Experimental | The experimental group was continuously pumped with remifentanil + ketamine for analgesia, and the control group was continuously pumped with remifentanil + placebo (normal saline) for analgesia. RASS and CPOT scores were performed to evaluate the pain degree of the patients. Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Supply and Oxygen Consumption
After the patient was admitted to ICU, femoral artery puncture and catheterization were performed to establish PICCO connection access. At 0h, 4h, 8h, 12h, 16h, 20h, 24h, 32h, 40h and 48h after surgery, ice saline injection was used to measure CO, and central vein and peripheral blood samples were collected for blood gas examination.According to the formula, the patient's oxygen supply and oxygen consumption were calculated: DO2=CO×CaO2×10;CaO2 = 1.34 * SaO2 + 0.003 * Hb PaO2;VO2 = CI x (CaO2 - CvO2).
Measured: 0-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start8 May 2021
- Primary completionMay 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingui Dai, First People's Hospital of Chenzhou
- Investigators
- Dixian DX Luo, MS, Study director, Chenzhou First People Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906915
- Sponsor's protocol ID
- ketamine
- Status last verified
- May 2021
- First submitted
- 25 May 2021
- Last updated
- 28 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT04906915
- Acronym / sponsor ID
- ketamine
- Conditions
- Intensive Care Unit
- Keywords
- Ketamine, Extracorporeal circulation, Oxygen Supply, Oxygen Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 8 May 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 28 May 2021 (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.
After cardiopulmonary bypass heart surgery, with the rewarming of body temperature, the metabolic capacity of the body is enhanced, the microcirculation is opened, and tissue perfusion is increased. At the same time, the body pays off the oxygen debt formed by the low temperature and reduced blood flow in cardiopulmonary bypass, so that the tissue oxygen demand increases and oxygen consumption increases.Analgesia and sedation are important treatment measures for patients after cardiopulmonary bypass. S-isomer of ketamine and eselamine enhanced the sedation and enhanced the analgesic effect, but whether it can improve the imbalance of oxygen supply and oxygen consumption after cardiopulmonary bypass is unknown.
Detailed description
After cardiopulmonary bypass, the body usually appears in a state of hypermetabolism. In addition to anesthesia resuscitation and recovery of spontaneous respiration, chills, pain and anxiety can increase oxygen demand, increased oxygen consumption is also related to a series of neuroendocrine reactions.At the same time, the body needs to repay the oxygen debt formed by low temperature and reduced blood flow in extracorporeal circulation, so that the tissue oxygen demand increases, and the systemic oxygen consumption is significantly higher than the normal physiological state.
Sedation and analgesia treatment is one of the important early treatment measures for patients after heart surgery. Patients with heart disease are prone to anxiety and restlessness due to reduced cardiac function reserve, severe surgical trauma and extracorporeal circulation, which can lead to hemodilution, tissue edema, ischemia and reperfusion injury, etc. In addition, patients with high preoperative mental stress are prone to anxiety and restlessness.Appropriate sedation and analgesia treatment is very important to reduce stress response, reduce oxygen consumption and maintain the stability of hemodynamics.
The application of ketamine in sedation and analgesia has the characteristics of high controllability, and it does not inhibit respiration and mildly excites circulation, but whether it can improve the imbalance of oxygen supply and demand in patients after cardiopulmonary bypass is unknown.Therefore, it is of great significance to investigate the effect of ketamine on oxygen supply and oxygen consumption of patients after cardiopulmonary bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketamine | Experimental | Drug: KetamineThe experimental group was continuously pumped with remifentanil + ketamine for analgesia, and the control group was continuously pumped with remifentanil + placebo (normal saline) for analgesia. RASS and CPOT scores were performed to evaluate the pain degree of the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive adult (>18years)patients after heart surgery
Key exclusion criteria (1 listed)
- Chronic kidney disease (CKD); ECMO or IABP assistance is required; Malignant tumor; Acquired immunodeficiency syndrome; receive psychiatric medication.
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 |
|---|---|---|
| KetamineThe efficacy of ketamine was assessed by calculating oxygen supply and consumption | Drug | Ketamine |
Primary outcome
Oxygen Supply and Oxygen Consumption
Time frame: 0-48 hours
After the patient was admitted to ICU, femoral artery puncture and catheterization were performed to establish PICCO connection access. At 0h, 4h, 8h, 12h, 16h, 20h, 24h, 32h, 40h and 48h after surgery, ice saline injection was used to measure CO, and central vein and peripheral blood samples were collected for blood gas examination.According to the formula, the patient's oxygen supply and oxygen consumption were calculated: DO2=CO×CaO2×10;CaO2 = 1.34 * SaO2 + 0.003 * Hb PaO2;VO2 = CI x (CaO2 - CvO2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
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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.
Dixian DX Luo, MS study director
Chenzhou First People Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Intensive Care Unit, run by First People's Hospital of Chenzhou at 1 site 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 1 inclusion and 1 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 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Mei XM Mei (86-17742594539 ext. 423000, 17742594539@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Supply and Oxygen Consumption (time frame: 0-48 hours). 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 28 May 2021.