Ovarian cancer
Conditions
Interventions
Background Group (A Group):Tegeline 6mg + Ondansetron 8mg diluted in normal saline to 0.025mg/ml, total volume 240ml. Background infusion rate set at 3ml/h (0.075mg/h), bolus dose 3ml per press, locko
Low Background Group (B Group):Tegeline 6mg + Ondansetron 8mg diluted in normal saline to 0.025mg/ml, total volume 240ml. Background infusion rate set at 1.5ml/h (0.0375mg/h), bolus dose 3ml per press
No Background Group (C Group):Tegeline 6mg + Ondansetron 8mg diluted in normal saline to 0.025mg/ml, total volume 240ml. No background infusion, bolus dose 3ml per press, lockout time 10 minutes
Sponsors
Chongqing University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-75 years; 2. Ovarian cancer patients with open surgery; 3. ASA grade I-III; 4. Voluntarily participate in and sign the informed consent;
Exclusion criteria
Exclusion criteria: 1. Obesity (BMI>28), OSA, previous opioid respiratory depression, pregnancy, and use of CYP3A4 drugs; 2. Preoperative chronic pain (pain lasting more than 3 months) or long-term use of analgesics (more than 3 months); 3. Severe hepatic and renal dysfunction (ALT/AST>3 times normal, creatinine clearance <30 mL/min), severe COPD; 4. long-term use of antipsychotic drugs in patients with psychosis; 5. Withdrawal from PCIA or switching to other analgesic regimens; 6. The patient was not eligible for the study for any other reason, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area Under the Curve of Numerical Rating Scale for Rest and Movement Pain Within 24 Hours Postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale for Rest and Movement Pain at 48 Hours Postoperatively;Ramsay Sedation Scale Scores in PACU and at 2, 6, 12, and 48 Hours Postoperatively;Self-rated Sleep Quality at 24 and 48 Hours Postoperatively;Patient and Family Satisfaction Scores at 24 and 48 Hours Postoperatively;Total and Effective PCA Presses and Drug Consumption at 24 and 48 Hours Postoperatively;Time to First Breakthrough Pain, Number of Rescue Analgesic Doses, and Cumulative Rescue Analgesic Consumption;Postoperative Adverse Events Including Respiratory Depression, Nausea and Vomiting, Constipation, etc.;Time to First Flatus and Time to First Ambulation;Quality of Recovery Score (QoR-15);Average Hospital Length of Stay; | — |
Countries
China
Contacts
Public ContactXiong Zhangrong, Feng Yumei
Chongqing University Cancer Hospital
Outcome results
None listed