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A Non-Inferiority Randomized Controlled Trial of Tegileridine for Postoperative Analgesia After Laparoscopic Cholecystectomy

A Non-Inferiority Randomized Controlled Trial of Tegileridine for Postoperative Analgesia After Laparoscopic Cholecystectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113901
Enrollment
Unknown
Registered
2025-12-04
Start date
2025-12-07
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

A patient under general anesthesia

Interventions

Experimental group:Patients in the experimental group received a slow intravenous infusion of 1 mg of tigeseridine 10 minutes before the end of surgery for postoperative analgesia. Anesthesia was indu
Control group:Patients in the control group received a slow intravenous infusion of 0.05 mg fentanyl 10 minutes before the end of surgery for postoperative analgesia. Anesthesia was induced with propo

Sponsors

Suzhou Ninth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years; 2. Anesthesia Society of America (ASA) grade I to II; 3. Body mass index (BMI) between 18 and 30 kg/m^2; 4. Patients scheduled for laparoscopic cholecystectomy; 5. Provision of signed informed consent preoperatively, with demonstrated ability to comprehend and comply with study procedures.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to opioid drugs or any component of the investigational drug; 2. Patients with a history of long-term use or abuse of opioid drugs; 3. Patients combined with severe cardiac, hepatic, or renal dysfunction or neuropsychiatric diseases; 4. Pregnant or lactating women; 5. Patients with a history of PONV or severe motion sickness; 6. Patients deemed ineligible for enrollment by the investigator.

Design outcomes

Primary

MeasureTime frame
Sum of Pain Intensity Differences over 24 hours;

Secondary

MeasureTime frame
Resting Numeric Rating Scale;Dosage of Opioid;Nausea;Vomiting;Adverse reaction incidence;Quality of Recovery-15;

Countries

China

Contacts

Public ContactChao Zhang

Suzhou Ninth People's Hospital

tony1345@163.com+86 188 6256 8088

Outcome results

None listed

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