Postoperative Nausea and Vomiting
Conditions
Interventions
Esketamine Group (E Group):Continuous infusion via PCIA pump of esketamine 1mg/kg (lean body weight) combined with dexmedetomidine 4ug/kg (lean body weight) and palonosetron 0.5mg, diluted to a total
background infusion rate of 2ml/h, bolus dose of 2ml, lockout interval of 15min
Control Group (C Group):Continuous infusion via PCIA pump of sufentanil 2ug/kg (lean body weight) combined with dexmedetomidine 4ug/kg (lean body weight) and palonosetron 0.5mg, diluted to a total vol
Sponsors
Huadong Hospital Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years; 2. American Society of Anesthesiologists (ASA) grade I–III; 3. Body mass index (BMI) between 30 kg/m^2 and 50 kg/m^2 (30 < BMI < 50); 4. Undergoing elective laparoscopic sleeve gastrectomy; 5. Voluntary participation in the study and provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1. Have a contraindication or allergy to esketamine, including severe cardiovascular or cerebrovascular diseases, uncontrolled hypertension, history of psychiatric disorders, history of substance abuse, hyperthyroidism, severe hepatic or renal insufficiency (Child-Pugh class C or eGFR < 30 mL/min/1.73m^2), etc. 2. Long-term use of antidepressants or other psychiatric medications within the past three months; 3. Hearing, visual, or speech impairments that affect scale assessment and communication; 4. Patients who develop severe postoperative complications such as major bleeding, cerebral infarction, pulmonary infection, or require reoperation; 5. Complicated by severe neurological or psychiatric disorders, or decompensation of other vital organs; 6. Inability or unwillingness to complete the study in accordance with the research protocol; 7. Participation in other drug clinical trials within the past 4 weeks; 8. Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of postoperative nausea and vomiting (PONV) within 48 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Postoperative quality of recovery (QoR-15 scale);Severity of nausea and vomiting and use of rescue antiemetics;Resting and dynamic pain scores at different postoperative time points (days 1–3, before discharge);Opioid consumption;Hospital Anxiety and Depression Scale (HADS);Enrollment rate;Adherence; | — |
Countries
China
Contacts
Public ContactGu Weidong
Huadong Hospital Hospital Affiliated to Fudan University
Outcome results
None listed