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Effect of esketamine on inflammatory response in patients undergoing open heart surgery under cardiopulmonary bypass - a prospective, randomized, controlled study

Effect of esketamine on inflammatory response in patients undergoing open heart surgery under cardiopulmonary bypass - a prospective, randomized, controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083176
Enrollment
Unknown
Registered
2024-04-17
Start date
2024-04-17
Completion date
Unknown
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart disease

Interventions

test group:Pump infusion of esketamine (0.5 mg/kg/h) during extracorporeal circulation
control group:Pump infusion of equal volume of normal saline during extracorporeal circulation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1).Age 18-70 years old; 2).Elective first cardiac surgery with midline thoracotomy under cardiopulmonary bypass; 3).ASA: Level I-III (Attachment 1); 4).NYHA cardiac function class II-III; 5).BMI=35; 6).Sign the informed consent form

Exclusion criteria

Exclusion criteria: 1). Past history of long-term opioid use; 2).Chronic pain patients; 3).Patients undergoing emergency surgery or re-operation; 4). Left ventricular EF180 minutes; 6). Patients who are not undergoing thoracotomy for the first time; 7).Patients with severely impaired functions of other important organs; 8).Pregnant and lactating women, preeclampsia or eclampsia; 9). Suffering from mental system diseases (such as schizophrenia, depression, etc.) and cognitive dysfunction; suffering from a history of epilepsy; past history of abuse of psychotropic drugs and narcotic drugs; 10). Patients at serious risk of increased intracranial pressure and intraocular pressure; 11). Patients with untreated or under-treated hyperthyroidism; 12). Those who are allergic to study drugs; 13). Unable to cooperate with the research for any reason or the researcher believes that it is not appropriate to be included in this trial;

Design outcomes

Primary

MeasureTime frame
Inflammatory response index PCT within 24 hours after surgery;Inflammatory response index IL-6 within 24 hours after surgery;Inflammatory response index CRP within 24 hours after surgery;

Secondary

MeasureTime frame
Intraoperative opioid dosage (converted to morphine);Dosage of rescue analgesics within 24 hours after surgery (converted into morphine);Awake time in ICU;Extubation time in ICU;NRS score 12 hours after extubation;NRS score 24 hours after extubation;NRS score 48 hours after extubation;NRS score 30 days after extubation;ICU stay time;length of stay in hospital;Incidence of postoperative nausea and vomiting;Reoperation rate;Postoperative complications (heart failure, lung infection, incision infection, etc.);Mortality within 30 days after surgery;Incidence of postoperative chronic pain ;Incidence of postoperative psychiatric reactions;

Countries

China

Contacts

Public ContactWang Xiao

West China Hospital of Sichuan University

1490829116@qq.com+86 189 8060 1549

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026