To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

June 14, 2024 updated by: Zhang XIao Mei

To Investigate the Effect of Esketamine on Hemodynamics and Postoperative Pulmonary Complications in Patients Undergoing Heart Valve Replacement Surgery

The objective of this study was to evaluate the effect of esketamine on intraoperative hemodynamics in patients with heart valve replacement and to mitigate postoperative pulmonary complications

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After being informed of the study and potential risks, all patients who gave written informed consent will undergo pre-operative screening to determine eligibility for study enrollment. Before operation, eligible patients were randomly divided into esketamine group (0.2mg/kg, intraoperative pump), esketamine group (0.4mg/kg, intraoperative pump) and blank control group (physiological salt pump) in a double-blind way at a ratio of 1:1:1.

Study Type

Interventional

Enrollment (Estimated)

102

Phase

  • Phase 4

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
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Recruiting
        • Affiliated Hospital Of Zunyi Medical University
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-75 years old, gender unlimited.
  • Elective heart surgery.
  • Patients who plan to undergo mitral and (or) aortic valve replacement (or repair) surgery, requiring extracorporeal circulation and aortic occlusion.
  • The New York Heart Association class is less than 4.
  • Voluntarily sign informed consent.

Exclusion Criteria:

  • Non-cardiac surgery.
  • Second heart surgery.
  • Interventional surgery in heart valve surgery (TAVI, mitral clamp).
  • The patient refuses.
  • Pregnant women.
  • Patients with a history of lung surgery.
  • Patients with acute kidney injury requiring dialysis.
  • Patients with chronic renal insufficiency (stage III and above).
  • The patient was intubated before arriving at the operating room.
  • Patients with existing pulmonary complications (respiratory tract infection, pneumonia, pleural effusion, respiratory failure, atelectasis, pneumothorax, bronchospasm, ARDS).
  • The patient had neuropsychiatric disease and cognitive impairment before surgery.
  • Drug users and other long-term use of antipsychotic drugs.
  • Patients with any of the following contraindications for the use of ESketamine injection: patients with serious risk of elevated blood pressure or intracranial pressure; Patients with high intraocular pressure (glaucoma) or penetrating ocular trauma; Patients with poorly controlled or untreated hypertension (arterial hypertension, resting systolic pressure exceeding 180 mmHg, or resting diastolic pressure exceeding 100mmHg); Patients with untreated or undertreated hyperthyroidism (hyperthyroidism).
  • Liver function ALT, AST > 2 times normal.

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: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: blank control group
In the blank control group, no intervention was used during the operation, and normal saline was pumped according to the participant's body weight until the end of the operation.
Experimental: Low dose esketamine hydrochloride injection group
In the low-dose ESketamine hydrochloride injection group, 50mg of Esketamine hydrochloride injection was diluted with normal saline into a 50ml syringe, which was wrapped with light-proof paper and pumped continuously from the beginning of anesthesia to the end of surgery. The dosage was calculated as 0.2mg/kg.h.
Drug: Esketamine hydrochloride injection
The low dose esketamine hydrochloride group was given 0.2mg/kg at induction of anesthesia, the high dose esketamine hydrochloride group was given 0.4mg/kg at induction of anesthesia, and the blank control group was not given Esketamine hydrochloride injection at induction of anesthesia.
Other Names:
  • 0.9% sodium chloride injection
Experimental: High dose esketamine hydrochloride injection group
In the high-dose ESketamine hydrochloride injection group, 50mg of Esketamine hydrochloride injection was diluted with normal saline into a 50ml syringe, which was wrapped with light-resistant paper and pumped continuously from the beginning of anesthesia to the end of surgery. Dosage was calculated as 0.4mg/kg.h.
Drug: Esketamine hydrochloride injection
The low dose esketamine hydrochloride group was given 0.2mg/kg at induction of anesthesia, the high dose esketamine hydrochloride group was given 0.4mg/kg at induction of anesthesia, and the blank control group was not given Esketamine hydrochloride injection at induction of anesthesia.
Other Names:
  • 0.9% sodium chloride injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary ultrasound score
Time Frame: Baseline and day 1, day 2 and day 3 after surgery
The anterior axillary line, posterior axillary line and paraspinal line were used as the boundary, and each lung was divided into 3 regions: anterior chest, underarm and back. Each area was given a maximum score of 3 out of 36, with higher scores indicating worse lung condition.
Baseline and day 1, day 2 and day 3 after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The concentration of interleukin 6
Time Frame: At baseline, before anesthesia induction, 10 minutes after insertion of tracheal catheter, 10 minutes after cardiopulmonary bypass, 10 minutes after completion of cardiopulmonary bypass, at the end of surgery, and 1 day after completion of surgery.
The concentration of interleukin-6 in participants before and during surgery, as well as after surgery, can reflect the size of the inflammatory response to some extent.
At baseline, before anesthesia induction, 10 minutes after insertion of tracheal catheter, 10 minutes after cardiopulmonary bypass, 10 minutes after completion of cardiopulmonary bypass, at the end of surgery, and 1 day after completion of surgery.

Collaborators and Investigators

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

Sponsor

Zhang XIao Mei

Investigators

  • Study Director: Wei Chen, Staff member of Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University
  • Principal Investigator: Haiying Wang, Director of anesthesiology Department, Affiliated Hospital of Zunyi Medical University

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)

January 1, 2024

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 21, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KLL-2023-223

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

After the clinical trial, each subgroup and its corresponding lung ultrasound score were shared with other research teams.

IPD Sharing Time Frame

Data related to this trial can be shared for a total of 6 months after publication.

IPD Sharing Access Criteria

Contact the head of the study for approval

IPD Sharing Supporting Information Type

  • CSR

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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