Tumours of the female reproductive organs
Conditions
Interventions
Group T (PCIA: Tegileridine 7.5mg + Dolasetron 60mg + normal saline, total 150ml):None
Group S(PCIA:Sufentanil 3µg/kg + Dolasetron 60mg + normal saline, total 150ml):None
Sponsors
Guangxi Medical University Cancer Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Undergoing elective gynaecological open tumour surgery under general anaesthesia, with an anticipated operative duration of >=1 hour; 2. Aged between 18 and 65 years; 3. ASA physical status classification I–III; 4. Body mass index (BMI) 18.0 kg/m^2 <= BMI <=28.0 kg/m^2; 5.No severe cardiovascular, hepatic, or renal dysfunction; 6. Signing of informed consent, demonstrating full understanding of the trial's purpose and significance, and voluntary adherence to the trial .
Exclusion criteria
Exclusion criteria: 1. Individuals with pre-existing chronic pain or those dependent on long-term opioid or analgesic medication; 2. Those with known allergy to the study drug; 3. Patients with a history of severe psychiatric disorders (e.g., schizophrenia, depression) or cognitive impairment rendering them unable to cooperate with assessments, or with a history of epilepsy or Parkinson's syndrome; 4. Known or suspected gastrointestinal obstruction, including paralytic ileus; 5.History of severe reflux oesophagitis; 6. History of vestibular dysfunction or symptoms including dizziness, nausea, dry heaving, or vomiting within 1 week prior to enrolment; 7.Patients undergoing combined gynaecological and gastrointestinal surgery during this procedure; 8. Patients with contraindications to regional anaesthesia; 9. Pregnant or lactating women; 10. Patients requiring transfer to the ICU postoperatively; 11. Participation in other drug clinical trials within 3 months prior to enrolment (defined as receiving investigational medicinal product or placebo); 12. Other circumstances where the investigator deems the subject unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Motility Score(Standard for Evaluation of Postoperative Gastrointestinal Motility in the Perioperative Period); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain Visual Analog Scale (VAS) scores at rest and during movement at 6h, 12h, 24h, 48h, and 72h postoperatively;The number of times the patient pressed the button to receive an additional dose of analgesic, and the need for additional analgesic interventions beyond the scheduled doses within 72 hours post-operation;Time of solid food intake after surgery;Time of the first ambulation after surgery;Postoperative length of stay;Ramsay Sedation Scores;Incidence of other adverse reactions; | — |
Countries
China
Contacts
Public ContactPei Shenglin
Guangxi Medical University Cancer Hospital
Outcome results
None listed