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

4 juin 2026 mis à jour par: Jihong Jiang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

84

Phase

  • Phase 4

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Tegileridine Group
Participants in this group will receive postoperative patient-controlled intravenous analgesia containing tegileridine 5 mg and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.
Médicament: Tegileridine
Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
Médicament: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Comparateur actif: Sufentanil Group
Participants in this group will receive postoperative patient-controlled intravenous analgesia containing sufentanil 100 micrograms and palonosetron 0.5 mg diluted with normal saline to a total volume of 100 mL. The analgesia pump will be administered intravenously at a background infusion rate of 1.5 mL/hour, with a bolus dose of 1.5 mL and a lockout interval of 15 minutes.
Médicament: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Médicament: Sufentanil
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
Délai: From 0 to 24 hours after admission to the PACU
The cumulative resting pain score within 24 hours after admission to the post-anesthesia care unit (PACU) will be represented by the area under the curve of the numeric rating scale (NRS) scores from 0 to 24 hours. Resting pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be measured at 0, 6, 12, 18, and 24 hours after admission to the PACU.
From 0 to 24 hours after admission to the PACU

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Resting and Movement Pain Intensity
Délai: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
Resting and movement pain intensity will be assessed using an 11-point NRS, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. NRS scores will be recorded at 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU.
At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
PCIA Demand and Effective Press Counts
Délai: Within 48 hours after admission to the PACU.
Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.
Within 48 hours after admission to the PACU.
Use of Rescue Analgesia
Délai: Within 72 hours after admission to the PACU
The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.
Within 72 hours after admission to the PACU
Incidence and Severity of PONV
Délai: Within 72 hours after admission to the PACU
The incidence and severity of postoperative nausea and vomiting (PONV) will be assessed using a standardized nausea and vomiting assessment scale within 72 hours after admission to the PACU.
Within 72 hours after admission to the PACU
Time to First Flatus
Délai: From admission to the PACU until first passage of flatus, assessed up to 1 week.
Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.
From admission to the PACU until first passage of flatus, assessed up to 1 week.
Time to First Bowel Movement
Délai: From admission to the PACU until first bowel movement, assessed up to 1 week.
Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.
From admission to the PACU until first bowel movement, assessed up to 1 week.
Time to Resumption of Oral Intake
Délai: From admission to the PACU until resumption of oral intake, assessed up to 1 week.
Time to resumption of oral intake will be defined as the time from admission to the PACU to the first postoperative intake of liquids, semi-liquid food, or regular diet.
From admission to the PACU until resumption of oral intake, assessed up to 1 week.
Length of Postoperative Hospital Stay
Délai: From admission to the PACU until hospital discharge, assessed up to 30 days.
Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.
From admission to the PACU until hospital discharge, assessed up to 30 days.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Changes in Inflammatory Biomarkers
Délai: Before surgery and at predefined time points within 72 hours after admission to the PACU
Serum levels of inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-alpha), will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on systemic inflammatory response.
Before surgery and at predefined time points within 72 hours after admission to the PACU
Changes in I-FABP
Délai: Before surgery and at predefined time points within 72 hours after admission to the PACU
Serum intestinal fatty acid-binding protein (I-FABP) levels will be measured before surgery and at predefined time points after admission to the PACU to explore the effects of analgesic medications on intestinal injury.
Before surgery and at predefined time points within 72 hours after admission to the PACU

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 janvier 2027

Achèvement de l'étude (Estimé)

1 juin 2027

Dates d'inscription aux études

Première soumission

29 avril 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

10 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • IIT-CRU-FAMB-2026HS100

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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