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Evaluation of the safety and efficacy of opioid anesthesia in non-cardiac surgery in patients at intermediate and high risk of nausea and vomiting

Evaluation of the safety and efficacy of opioid anesthesia in non-cardiac surgery in patients at intermediate and high risk of nausea and vomiting

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077224
Enrollment
Unknown
Registered
2023-11-01
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

postoperative complications

Interventions

Control group (Group C):Anesthesia induction: midazolam 2-4mg, etomidate 8-12mg, sufentanil 0.3-0.6ug/kg, benzenesulfoncis-atracurium 10-15mg, palonosetron 0.075mg
anesthesia maintenance: intravenous infusion 0.1-1.0mg/kg/h refentanil + propofol 4-12mg/kg/h
Postoperatively: PCIA pump, sufentanil 0.03ug/kg/h + tuosetron 10mg
Esketamine group (group K):Anesthesia induction: midazolam 2-4mg, etomidate 8-12mg, esketamine 0.5-1mg/kg, besysulfoncis-atracurium 10-15mg, palonosetron 0.075mg
anesthesia maintenance: intravenous infusion of esketamine + propofol 4-12mg/kg/h
Postoperatively: PCIA, esketamine 0.03mg/kg/h + sterasetron 10mg

Sponsors

Xuzhou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age 18-75; 2) Patients who are expected to undergo laparoscopic thoracic and abdominal surgery with an operation time of =4h; 3) ASA Grading I-III; 4) Patients with 2 or more risk factors for PONV; 5) No communication barrier, clear consciousness; 6) BMI of 18.5-29.9 kg/m2; 7) voluntary use of postoperative venous analgesia devices; 8) Ethically, patients voluntarily undergo testing and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) Those who have contraindications or allergies to esketamine and other narcotic drugs; 2) Those who are identified/suspected of abuse or long-term use of narcotic sedative analgesics; 3) Severe hypertension and severe cardiovascular disease; 4) Have had any cerebrovascular accident within 3 months; 5) Pulmonary hypertension, intracranial pressure or intraocular hypertension; 6) history of psychiatric illness, central nervous system injury; 7) Severe liver and kidney dysfunction; 8) History of antiemetic drug use within 24 hours.

Design outcomes

Primary

MeasureTime frame
The incidence and severity of PONV in 2h, 12h, and 24h postoperative period;

Secondary

MeasureTime frame
Perioperative plasma motilin (MTL) and serotonin (5-HT3) levels;Level of inflammatory response (IL-1ß, IL-6, TNF-a serological concentrations);MMSE score;Changes in perioperative hemodynamics;Postoperative pain score;Postoperative anxiety;

Countries

China

Contacts

Public ContactQi Yu

Xuzhou Central Hospital

qiyu1987xiaobao@163.com+86 177 1298 8986

Outcome results

None listed

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