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Study on the efficacy and safety of sub-dose Tegilidine for postoperative analgesia in elderly patients undergoing laparoscopy: a prospective, randomized, double-blind controlled trial

Study on the efficacy and safety of sub-dose Tegilidine for postoperative analgesia in elderly patients undergoing laparoscopy: a prospective, randomized, double-blind controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100070
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-07-01
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

abdominal diseases

Interventions

Tegileredine group:30 minutes before the end of the surgery, intravenous injection of a loading dose of 0.5 mg (5 mL), a single dose of 0.05 mg (1 mL) from a PCA pump, and locking for 20 minutes.
Sufentanail group:30 minutes before the end of the surgery, a loading dose of 5 ug (5 mL) was intravenously injected, and a single dose of 0.5 ug (1 mL) was administered through a PCA pump, which was

Sponsors

Chengdu Jinniu District People’s hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age >=65 years old, gender is not limited; 2. ASA I-III grade; 3. Patients who plan to undergo elective laparoscopic surgery under general anesthesia with intubation; 4. Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Known or suspected history of opioid intolerance; 2. Severe respiratory depression, such as oxygen saturation below 90%; 3. Having a history of chronic pain or using opioids or other pain modulators within the previous 2 weeks; 4. Acute or severe bronchial asthma; 5. Severe hepatic insufficiency; 6. Known or suspected gastrointestinal obstruction, including paralytic ileus; 7. Seizures; 8. Known or suspected history of alcoholism or drug abuse; 9. Severe cardiovascular diseases such as unstable angina pectoris and severe arrhythmia; 10. Other chronic diseases that may affect postoperative pain assessment, such as diabetic neuropathy.

Design outcomes

Primary

MeasureTime frame
Static and dynamic VAS scores;Occurrence of adverse events;

Secondary

MeasureTime frame
Total opioid use;Satisfaction with analgesia;

Countries

China

Contacts

Public ContactGuiying Qi

Chengdu Jinniu District People’s hospital

396920240@qq.com+86 136 7804 4229

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026