To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications

NCT06467513 | Recruiting Phase 4 DMC

• 1 other identifier: KLL-2023-223
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Diseases; Heart Valve Diseases

Outcome Measures

Primary Outcomes (1)

• Pulmonary ultrasound score

  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 Outcomes (1)

• The concentration of interleukin 6

  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.

Study Arms (3)

blank control group

NO INTERVENTION

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.

Low dose esketamine hydrochloride injection group

EXPERIMENTAL

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

High dose esketamine hydrochloride injection group

EXPERIMENTAL

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

Interventions

Esketamine hydrochloride injection DRUG

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.

Also known as: 0.9% sodium chloride injection

High dose esketamine hydrochloride injection group; Low dose esketamine hydrochloride injection group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang XIao Mei: lead

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

RECRUITING

MeSH Terms

Conditions

Heart Diseases; Heart Valve Diseases

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Wei Chen

  Staff member of Department of Anesthesiology, Affiliated Hospital of Zunyi Medical University

  STUDY DIRECTOR

• Haiying Wang

  Director of anesthesiology Department, Affiliated Hospital of Zunyi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaomei Zhang

CONTACT

+0086 18786233321; 3233598996@qq.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomized personnel of the study enrolled suitable patients according to the random number table method before surgery, and then extracted drugs for anesthesia (anesthesia and patients did not know the group). The group status was not known to the post-operative follow-up personnel or the data analysts.
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiology resident, Affiliated Hospital of Zunyi Medical University

Model Details: This study was divided into 3 groups, one group was placebo group, the other group was low-dose esketamine group (continuous injection of esketamine until the end of surgery), the dose was 0.2mg/kg; The other group was the Esketamine high-dose group (the continuous injection of esketamine during the operation until the end of the operation) with a dose of 0.4mg/kg.

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data related to this trial can be shared for a total of 6 months after publication.
• Access Criteria: Contact the head of the study for approval

Locations

CN (1)