NCT04906915

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2021

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 28, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 28, 2021

Status Verified

May 1, 2021

Enrollment Period

12 months

First QC Date

May 25, 2021

Last Update Submit

May 25, 2021

Conditions

Keywords

KetamineExtracorporeal circulationOxygen SupplyOxygen Consumption

Outcome Measures

Primary Outcomes (1)

  • 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).

    0-48 hours

Study Arms (1)

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.

Drug: Ketamine

Interventions

The efficacy of ketamine was assessed by calculating oxygen supply and consumption

Ketamine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Chronic kidney disease (CKD); ECMO or IABP assistance is required; Malignant tumor; Acquired immunodeficiency syndrome; receive psychiatric medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital Chenzhou

Chenzhou, Hunan, 450003, China

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Dixian DX Luo, MS

    Chenzhou First People Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Critical Care Medicine

Study Record Dates

First Submitted

May 25, 2021

First Posted

May 28, 2021

Study Start

May 8, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 28, 2021

Record last verified: 2021-05

Locations