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

May 25, 2021 updated by: Xingui Dai, First People's Hospital of Chenzhou
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Chenzhou, Hunan, China, 450003
        • Recruiting
        • First Hospital Chenzhou
        • Contact:
          • Xingui XG Dai, MD
          • Phone Number: 18175708210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Ketamine
The efficacy of ketamine was assessed by calculating oxygen supply and consumption

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0-48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First People's Hospital of Chenzhou

Investigators

  • Study Director: Dixian DX Luo, MS, Chenzhou First People Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2021

Primary Completion (Anticipated)

May 1, 2022

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

May 25, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KETAMINE (Other Identifier: Institut Bergonié)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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