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Tegileridine Patient-Controlled Intravenous Analgesia for Postoperative Respiratory Function and Analgesic Efficacy in OSA and Obese Patients Undergoing Major Abdominal Surgery: A Randomized, Prospective, Multicenter Study

Tegileridine Patient-Controlled Intravenous Analgesia for Postoperative Respiratory Function and Analgesic Efficacy in OSA and Obese Patients Undergoing Major Abdominal Surgery: A Randomized, Prospective, Multicenter Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118617
Enrollment
Unknown
Registered
2026-02-09
Start date
2026-02-20
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

None

Interventions

Group S:Sufentanil 100 µg diluted to 100 mL, loading dose 5 µg, background infusion 2 mL/h, bolus 0.5 µg, lock-out 15 min.
Group T:Tegileridine 10 mg diluted to 100 mL, loading dose 1.5–2.0 mg, background infusion 2 mL/h, bolus 0.05 mg, lock-out 15 min.

Sponsors

Shaoxing People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ASA class I–III, aged 18–80 years, scheduled for major abdominal surgery (e.g., laparoscopic radical gastrectomy, gastric sleeve surgery colorectal resection, hepatectomy, radical prostatectomy), BMI >30 kg/m² or pre-operatively diagnosed obstructive sleep apnea, receiving intravenous patient-controlled analgesia (PCIA), mentally competent, able to understand VAS and operate PCIA pump, expected surgical time >=120 min.

Exclusion criteria

Exclusion criteria: Difficult airway, pre-operative percutaneous oxygen saturation (SpO2) <90%, allergy to study drugs (sufentanil, tegileridine, etc.), use of medications that may affect study results within 24 h before surgery (e.g., opioids, sedatives), severe dysfunction of vital organs (heart, lung, liver, kidney), serious respiratory diseases other than OSA, history of drug dependence or substance abuse, refusal to participate.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of impaired respiratory function within 0–24 hours postoperatively;

Countries

China

Contacts

Public ContactZongming Jiang

Shaoxing People's Hospital

jiangzhejiang120@163.com+86 135 1585 2725

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026