To Investigate the Effect of Esketamine Hydrochloride on Pulmonary Complications
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhang XIao Mei
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Non-cardiac surgery.
Second heart surgery.
Interventional surgery in heart valve surgery (TAVI, mitral clamp).
The patient refuses.
Trial design
Design model
Sequential
Treatments tested in this trial
Esketamine hydrochloride injection
DrugThe 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.
Treatment groups
102 Participants
are divided into 3 treatment groupsGroup A: blank control groupNo intervention 0 interventions
Group B: Low dose esketamine hydrochloride injection groupExperimental treatment 1 intervention
Group C: High dose esketamine hydrochloride injection groupExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and day 1, day 2 and day 3 after surgerySecondary outcomes
1
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.Sponsors and contacts
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Zhang XIao Mei
Lead sponsor
Zunyi Medical College
Sponsor institution
Source ClinicalTrials.gov