Bowel injury (intestinal ischaemia-reperfusion injury)
Conditions
Interventions
Trial Group 2 (Group A2):Preoperatively, intravenous administration of 2 mg of oliceridine
postoperatively, patient-controlled intravenous analgesia (PCIA) with oliceridine at a dose of 0.4 mg/kg.
Trial Group 1 (Group A1):Preoperatively, intravenously administer 2 mg of oliceridine
postoperatively, deliver oliceridine via patient-controlled intravenous analgesia (PCIA) at a dose of 0.4 mg/kg.
Control Group (Group C):Preoperatively, intravenously administer an equal volume of normal saline
postoperatively, deliver sufentanil via patient-controlled intravenous analgesia (PCIA) at a dose of 2 µg/kg.
Sponsors
The affiliated hospital of southwest medical university
Eligibility
Sex/Gender
Female
Age
30 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age: >=30 years old and <= 60 years old; 2.ASA classification: Grade I-II; 3.Body mass index (BMI) 18-25kg/m^2; 4.No confirmed gastrointestinal disease; 5.No history of drug allergy or abnormal anaesthesia; 6.Patients undergoing elective laparoscopic total hysterectomy under general anaesthesia; 7.Received postoperative intravenous self-controlled analgesic pump (PCIA) therapy; 8.Volunteer to be tested and sign an informed consent form. 9.Surgery duration: 1 to 3 hours.
Exclusion criteria
Exclusion criteria: 1.Patients with a history of opioid allergy; 2.Patients treated with chronic opioids; 3.Patients who have used any analgesic drug prior to surgery and are still within 5 half-lives (or within 48 hours if half-life is unknown); 4.Patients treated with chronic non-steroidal anti-inflammatory drugs; 5.Patients using medications that may affect analgesic efficacy (central a-adrenergic drugs, antiepileptics, neuroleptics, antidepressants, antipsychotics); 6.Patients with ECG abnormalities (QTcF interval > 450ms in males and > 470ms in females at screening); 7.Patients with a confirmed diagnosis of type 1 or type 2 diabetes, or those with a screening glycated hemoglobin (HbA1c) level = 6.5%, or a fasting blood glucose level = 7.0 mmol/L; 8.Patients with inflammatory bowel disease (Crohn's disease, ulcerative colitis), irritable bowel syndrome, chronic constipation (Bristol Stool Scale 1-2 with frequency <3 times/week), chronic diarrhea, or a history of acute gastroenteritis within 3 months prior to screening; 9.Patients with autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus) or those who have used immunosuppressive agents within one month prior to screening; 10.Patients with liver or kidney damage at the time of selection; 11.Individuals deemed ineligible for enrollment by the investigator; 12.Other postoperative exclusion criteria include signs of hemodynamic instability or respiratory dysfunction, or the occurrence of surgical/anesthetic complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal ischaemia-reperfusion injury;Oxidative stress;Inflammation response;Visual analogue scoring;QoR-15 Score (Quality of Recovery 15-item Postoperative Assessment);QTcF interval;Adverse reactions: 24 hours post-surgery, 48 hours post-surgery (nausea, vomiting, constipation, respiratory depression, pruritus, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Time of first flatus and bowel movement after surgery;Patient and family satisfaction with postoperative pain management; | — |
Countries
China
Contacts
Public ContactZhou Jun
The affiliated hospital of southwest medical university
Outcome results
None listed