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Efficacy and safety of oliceridine for postoperative patient-controlled intravenous analgesia in elderly patients undergoing laparoscopic radical resection of gastrointestinal tumors: a non-inferiority study

Efficacy and safety of oliceridine for postoperative patient-controlled intravenous analgesia in elderly patients undergoing laparoscopic radical resection of gastrointestinal tumors: a non-inferiority study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090780
Enrollment
Unknown
Registered
2024-10-13
Start date
2024-12-25
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

gastrointestinal tumor

Interventions

Sufentanil group (Group S):PCIA with sufentanil
Oliceridine group (Group O):PCIA with oliceridine

Sponsors

Tangdu Hospital, Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who plan to undergo elective laparoscopic radical surgery for gastrointestinal tumors under general anesthesia; 2. ASA grade I-III; 3. BMI 18-30 kg/m²; 4. Age ?60 years; 5. Primary tumor 6. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients with primary organ dysfunction such as liver and kidney, severe systemic diseases, and hematological disorders; 2.Patients with other malignant tumors at the same time; 3.History of other organ metastases diagnosed by imaging or pathology; 4.Chronic pain, long-term use of analgesics and psychotropic drugsdue to mental or neurological disorders, or psychiatric drugs abuse; 5.Patients who have used sedatives, antiemetic drugs and anti itch drugs within 24 hours before surgery or antidepressants within 15 days; 6.Patients who were allergic to opioid in the past or allergic to the investigational drug severely; 7.Patients with esophageal reflux disease and active peptic ulcers; 8.Patients who have severe respiratory depression, those who may develop acute or severe bronchial asthma, and those who are known or suspected to be gastrointestinal obstruction; 9.Patients who have communication barriers, unable to cooperate with researchers (severe hearing or visual impairment, language comprehension impairment, illiteracy, mental illness, history of epilepsy, Parkinson's disease, or myasthenia gravis), unable to use pain pumps after teaching.

Design outcomes

Primary

MeasureTime frame
Area under the curve of pain score at rest 0-48 hours after surgery;

Secondary

MeasureTime frame
Area under the curve of pain scores during 0-48 hours of exercise;The serum indicators of stress response to pain;The incidence and of adverse reactions after surgery ;The dose and proportion of patients using rescue analgesics within 48 hours after surgery;Patient satisfaction with pain relief;Ramsay;Postoperative vital signs (BP, HR, oxygen saturation, etc.);Postoperative cognitive function;Postoperative sleep quality;Time to first postoperative flatus;Total length of hospital stay;The number of effective presses and actual effective dosage of analgesic pump;Postoperative time to get out of bed;Removal time of drainage tube;

Countries

China

Contacts

Public ContactChangjun Gao

Tangdu Hospital, Air Force Medical University

gaocj74@163.com+86 133 7922 7869

Outcome results

None listed

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