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Effect of Postoperative Tegileridine Patient-Controlled Intravenous Analgesia on Overall Analgesic Benefit in Elderly Patients Undergoing Major Open Abdominal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Controlled Clinical Trial

Effect of Postoperative Tegileridine Patient-Controlled Intravenous Analgesia on Overall Analgesic Benefit in Elderly Patients Undergoing Major Open Abdominal Surgery: A Prospective, Randomized, Double-Blind, Parallel-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129346
Enrollment
Unknown
Registered
2026-08-03
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Postoperative pain after major open abdominal surgery in the elderly

Interventions

Tegileridine Group:Postoperative analgesia with Tegileridine via patient-controlled analgesia (PCA).
Control Group:Postoperative analgesia with Sufentanil via patient-controlled analgesia (PCA).

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 65 years; 2.Elective surgery planned with a laparotomy incision and an anticipated surgical duration of >=2 hours, including open radical/resection procedures involving the stomach, liver, gallbladder, pancreas, spleen, colon, or rectum; 3.American Society of Anesthesiologists (ASA) physical status classification I–III; 4.Capable of understanding and completing the OBAS, HADS, RCSQ, and QoR-15 assessment scales; 5.Preoperative Mini-Cog score >= 3; 6.Fully informed about the study protocol and voluntarily participating with signed informed consent;

Exclusion criteria

Exclusion criteria: 1.Allergy to study drugs; 2.Severe hepatic or renal dysfunction (Child-Pugh class C or requiring renal replacement therapy); 3.Long-term use of sedatives, antidepressants, or history of psychoactive substance abuse, including alcohol dependence; 4.History of severe central nervous system disorders, documented cognitive impairment, dementia, delirium, psychiatric illness, or language communication barriers; 5.Chronic pain, neuropathic pain, or long-term use of analgesics; 6.Inability to complete pain assessment; 7.Morbid obesity with BMI > 35 kg/m^2;

Design outcomes

Primary

MeasureTime frame
Cumulative OBAS Score;

Secondary

MeasureTime frame
Incidence and frequency of rescue analgesia;OBAS single-time scoring;Additional rescue opioid consumption expressed as morphine equivalents;QoR-15 scores;Incidence of respiratory depression or excessive sedation;Incidence of PONV;HADS Score;RCSQ scores;Postoperative complications;Incidence of Delirium;Length of postoperative hospital stay;All-cause 30-day mortality;health-related quality of life;

Countries

China

Contacts

Public ContactLiu Huayue

The First Affiliated Hospital of Soochow University

docliu.hy@suda.edu.cn+86 512 67973338

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026