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A Randomized Controlled Study of Fumarate Tegileridine versus Sufentanil for Postoperative Analgesia in Abdominal Surgery: A Comparison of Efficacy and Safety

A Randomized Controlled Study of Fumarate Tegileridine versus Sufentanil for Postoperative Analgesia in Abdominal Surgery: A Comparison of Efficacy and Safety

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114360
Enrollment
Unknown
Registered
2025-12-10
Start date
2026-01-01
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Postoperative Analgesia

Interventions

Tegileridine Group:Loading dose: Slowly intravenously inject 0.05 mg/kg of telitacicept fumarate before the end of the surgery. PCIA regimen: Telitacicept fumarate 0.05 mg/ml + tropisetron 10 mg + nor
Sufentanil Group:Loading dose: Slowly inject 10 µg sufentanil intravenously before the end of the surgery. PCIA regimen (departmental routine): sufentanil 2 µg/kg + tropisetron 10 mg + normal saline t

Sponsors

The Second Affiliated Hospital of Xinjiang Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients undergoing abdominal surgery in the general surgery department; 2. Aged 18 <=age <=65, meeting American Society of Anesthesiologists (ASA) physical status classification I–III; 3. Body Mass Index (BMI) 18.5 <= BMI <=30; 4. No significant abnormalities noted on preoperative electrocardiogram and pulmonary function tests; 5. Patients who have received informed consent and signed the surgical and general anaesthesia consent forms.

Exclusion criteria

Exclusion criteria: 1. Patients with severe chronic obstructive pulmonary disease, bronchial asthma or other respiratory conditions, difficult airways, or significant respiratory depression (oxygen saturation below 90%); 2. Patients with known or suspected gastrointestinal obstruction, including paralytic ileus; 3. Individuals with a history of substance abuse (including drug abuse, alcohol abuse, or addiction); 4. Patients with severe psychiatric disorders requiring anti-anxiety medication, sedatives, antipsychotics, or other opioid medications; 5. Patients with severe cardiac, hepatic, renal, or other organ diseases; 6. Concomitant use of known QT interval-prolonging medications (e.g., moxifloxacin, quinidine, amiodarone) or underlying conditions associated with QT prolongation (e.g., ventricular arrhythmias, untreated hypokalaemia or hypomagnesaemia); 7. Coagulation disorders; severe hypovolaemia or hypotension; 8. Concurrent immune or haematological system disorders; 9. Patients undergoing conversion to open surgery; 10. Individuals with known hypersensitivity to opioids or any component of this product.

Design outcomes

Primary

MeasureTime frame
VAS;

Secondary

MeasureTime frame
Respiratory rate;Pulse oximetry;

Countries

China

Contacts

Public ContactYuan Yingchuan

The Second Affiliated Hospital of Xinjiang Medical University

yyc84_315@163.com+86 186 9902 3360

Outcome results

None listed

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