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

4. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

84

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Tegileridine
Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
Legemiddel: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Aktiv komparator: 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.
Legemiddel: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Legemiddel: Sufentanil
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Resting and Movement Pain Intensity
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in Inflammatory Biomarkers
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. januar 2027

Studiet fullført (Antatt)

1. juni 2027

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

10. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IIT-CRU-FAMB-2026HS100

Plan for individuelle deltakerdata (IPD)

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NEI

IPD-planbeskrivelse

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

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Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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