Heart Diseases, Heart Valve Diseases
Conditions
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
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.
Interventions
DRUGEsketamine 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.
Sponsors
Zhang XIao Mei
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary ultrasound score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
China
Contacts
Primary ContactXiaomei Zhang
Outcome results
None listed