A Phase 4 interventional study of Esketamine hydrochloride injection in Heart Diseases and Heart Valve Diseases, sponsored by Zhang XIao Mei. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Zhang XIao Mei · Phase 4, Interventional, and Other
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 102 is close to the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →This is the only study on the registry with Zhang XIao Mei as lead sponsor.
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Exclusion Criteria:
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.
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
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.
Also known as: 0.9% sodium chloride injection
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.
Time frame: Baseline and day 1, day 2 and day 3 after surgery
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.
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.
Plan to share: Yes — After the clinical trial, each subgroup and its corresponding lung ultrasound score were shared with other research teams.
Supporting information: Csr
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