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Not yet recruiting NCT07637968

Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery

Phase IV Interventional Postoperative Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tegileridine, Sufentanil, Palonosetron.
Who it may be relevant to
Registry conditions: Postoperative Pain. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Tegileridine Versus Sufentanil for Postoperative Analgesia and Gastrointestinal Tolerability After Major Laparoscopic Abdominal Surgery: A Single-Center, Randomized, Triple-Blind Trial

Overview

This study is a single-center, randomized, triple-blind clinical trial designed to compare tegileridine and sufentanil for postoperative analgesia and gastrointestinal tolerability in patients undergoing major laparoscopic abdominal surgery. Participants will be randomly assigned to receive either tegileridine or sufentanil for postoperative patient-controlled intravenous analgesia according to the study protocol. The purpose of this study is to determine whether tegileridine can provide better gastrointestinal tolerability while maintaining non-inferior postoperative pain control compared with sufentanil in this patient population.

Interventions

  • Drug Tegileridine
    Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
  • Drug Sufentanil
    Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
  • Drug Palonosetron
    Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.

Primary outcome measures

  • Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU [Time frame: From 0 to 24 hours after admission to the PACU]
Secondary outcome measures (8)
  • Resting and Movement Pain Intensity [Time frame: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU]
  • PCIA Demand and Effective Press Counts [Time frame: Within 48 hours after admission to the PACU.]
  • Use of Rescue Analgesia [Time frame: Within 72 hours after admission to the PACU]
  • Incidence and Severity of PONV [Time frame: Within 72 hours after admission to the PACU]
  • Time to First Flatus [Time frame: From admission to the PACU until first passage of flatus, assessed up to 1 week.]
  • Time to First Bowel Movement [Time frame: From admission to the PACU until first bowel movement, assessed up to 1 week.]
  • Time to Resumption of Oral Intake [Time frame: From admission to the PACU until resumption of oral intake, assessed up to 1 week.]
  • Length of Postoperative Hospital Stay [Time frame: From admission to the PACU until hospital discharge, assessed up to 30 days.]

Eligibility criteria

Inclusion criteria

  • Age 18-75 years.
  • Elective major abdominal surgery as defined above.
  • Body mass index (BMI) 18-30 kg/m².
  • American Society of Anesthesiologists (ASA) physical status I to III.
  • Written informed consent.

Exclusion criteria

  • Known hypersensitivity to opioids or any component of the study medications.
  • Clinically significant hypoxemia, such as oxygen saturation less than 90 percentage, or a history of severe asthma.
  • Known or suspected gastrointestinal obstruction, including paralytic ileus.
  • Pregnancy or breastfeeding.
  • Severe hepatic impairment (Child-Pugh class C).
  • Severe heart failure (NYHA class III-IV) or unstable arrhythmia.
  • Neurological or psychiatric disorders that may interfere with pain or sedation assessment (e.g., epilepsy, impaired consciousness, uncontrolled psychiatric illness).
  • History of chronic pain or long-term use of analgesics/analgesic products.
  • Current use of sedative-hypnotic medications.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07637968 · IIT-CRU-FAMB-2026HS100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗