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Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT04906915
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : May 28, 2021
Sponsor:
Information provided by (Responsible Party):
Xingui Dai, First People's Hospital of Chenzhou

Tracking Information
First Submitted Date  ICMJE May 25, 2021
First Posted Date  ICMJE May 28, 2021
Last Update Posted Date May 28, 2021
Actual Study Start Date  ICMJE May 8, 2021
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery
Official Title  ICMJE Effect of Ketamine Assisted Analgesia on Oxygen Supply and Oxygen Consumption in Patients After Cardiac Surgery
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Intensive Care Unit
Intervention  ICMJE Drug: Ketamine
The efficacy of ketamine was assessed by calculating oxygen supply and consumption
Study Arms  ICMJE Experimental: Ketamine
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.
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 25, 2021)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Consecutive adult (>18years)patients after heart surgery

Exclusion Criteria:

  • Chronic kidney disease (CKD); ECMO or IABP assistance is required; Malignant tumor; Acquired immunodeficiency syndrome; receive psychiatric medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mei XM Mei 86-17742594539 ext 423000 17742594539@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04906915
Other Study ID Numbers  ICMJE ketamine
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Xingui Dai, First People's Hospital of Chenzhou
Original Responsible Party Same as current
Current Study Sponsor  ICMJE First People's Hospital of Chenzhou
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Dixian DX Luo, MS Chenzhou First People Hospital
PRS Account First People's Hospital of Chenzhou
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP