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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of interleukin 6 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaomei Zhang | Contact | +0086 18786233321 | 3233598996@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University | Recruiting | Zunyi | Guizhou | 563000 | China |
After the clinical trial, each subgroup and its corresponding lung ultrasound score were shared with other research teams.
Data related to this trial can be shared for a total of 6 months after publication.
Contact the head of the study for approval
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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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.
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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.
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| D017670 |
| Sodium Compounds |