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

4 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

84

Estágio

  • Fase 4

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Medicamento: Tegileridine
Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
Medicamento: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Comparador Ativo: 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.
Medicamento: Palonosetron
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Medicamento: Sufentanil
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Resting and Movement Pain Intensity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Changes in Inflammatory Biomarkers
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de junho de 2026

Conclusão Primária (Estimado)

1 de janeiro de 2027

Conclusão do estudo (Estimado)

1 de junho de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

29 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

4 de junho de 2026

Primeira postagem (Real)

10 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

10 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

4 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • IIT-CRU-FAMB-2026HS100

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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