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Effects of Biased Opioid Agonists on Gastrointestinal Recovery After Gynecologic Laparoscopic Surgery

3 novembre 2026 aggiornato da: Shuangqing Wu, Hainan Medical College

Effects of Biased Opioid Receptor Agonists on Postoperative Gastrointestinal Function Recovery in Patients Undergoing Gynecologic Laparoscopic Surgery

This randomized controlled clinical trial aims to evaluate the effects of different opioid analgesics on gastrointestinal recovery after gynecologic laparoscopic surgery.

Opioid medications are commonly used to manage pain after surgery, but they may cause nausea, vomiting, constipation, and delayed recovery of bowel function. Biased μ-opioid receptor agonists, such as tegileridine and oliceridine, may provide effective pain relief with fewer gastrointestinal side effects than conventional opioids.

The main question is whether biased opioid receptor agonists can shorten the time to postoperative gastrointestinal recovery compared with sufentanil, a conventional opioid analgesic.

The study plans to enroll 212 adults undergoing elective gynecologic laparoscopic surgery. Participants will be randomly assigned to one of four groups:

  • Lower-dose tegileridine
  • Higher-dose tegileridine
  • Oliceridine
  • Sufentanil

After surgery, participants will receive the assigned medication through a patient-controlled intravenous analgesia (PCIA) pump.

The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time.

Researchers will also assess the time to first passage of flatus, postoperative nausea and vomiting, gastrointestinal function scores, pain intensity, gastrointestinal ultrasound findings, analgesic requirements, and medication-related adverse events.

The findings may help determine whether biased opioid receptor agonists offer advantages over conventional opioid analgesics in supporting gastrointestinal recovery while maintaining adequate postoperative pain control.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Postoperative gastrointestinal dysfunction is a common concern following gynecologic laparoscopic surgery. Although opioid analgesics are widely used for postoperative pain management, their effects on gastrointestinal motility may contribute to delayed bowel function recovery, postoperative nausea and vomiting, and patient discomfort.

Biased μ-opioid receptor agonists have been developed to provide analgesia through preferential activation of specific opioid receptor signaling pathways. Tegileridine and oliceridine are of clinical interest because of their potential to provide effective postoperative analgesia while reducing certain opioid-associated adverse effects. However, their effects on gastrointestinal recovery following gynecologic laparoscopic surgery remain to be established.

This study is a prospective, randomized, controlled, single-center clinical trial conducted at the Second Affiliated Hospital of Hainan Medical University. A total of 212 adult patients undergoing elective gynecologic laparoscopic surgery are planned to be enrolled.

Participants will be randomly allocated to four parallel treatment groups receiving postoperative patient-controlled intravenous analgesia (PCIA) with one of the following regimens:

  • Tegileridine 0.07 mg/kg
  • Tegileridine 0.11 mg/kg
  • Oliceridine 0.36 mg/kg
  • Sufentanil 2.0 micrograms/kg

The primary outcome is time to gastrointestinal recovery (GI-2), defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. GI-2 recovery time is determined by the later of these two events and is measured in hours.

Secondary outcomes include time to first passage of flatus, time to first bowel movement, postoperative gastrointestinal function assessed using the I-FEED score, postoperative nausea and vomiting, postoperative pain intensity assessed using the Visual Analog Scale (VAS), patient-controlled analgesia use, rescue analgesia requirements, and medication-related adverse events.

Gastrointestinal ultrasound examinations will be performed to assess postoperative gastrointestinal function, including gastric antral cross-sectional area and small bowel peristaltic activity. These measurements are intended to provide additional objective information about gastrointestinal recovery.

The study will compare postoperative gastrointestinal recovery, analgesic effectiveness, and safety outcomes across the four treatment groups. The findings may provide clinical evidence to inform the selection of postoperative opioid analgesic regimens for patients undergoing gynecologic laparoscopic surgery.

Tipo di studio

Interventistico

Iscrizione (Stimato)

212

Fase

  • Fase 4

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Hainan
      • Haikou, Hainan, Cina, 571199
        • Reclutamento
        • The Second Affiliated Hospital of Hainan Medical University
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Female patients aged 18 to 75 years scheduled for elective gynecologic laparoscopic surgery.
  • American Society of Anesthesiologists (ASA) physical status I-III.
  • Body mass index (BMI) between 18 and 30 kg/m².
  • Normal preoperative liver and kidney function, with cardiopulmonary function adequate to tolerate surgery.
  • Voluntary provision of written informed consent.

Exclusion Criteria:

  • Inability to provide informed consent before surgery or difficulty communicating.
  • Known allergy to any of the study medications.
  • Severe hepatic impairment (Child-Pugh class C), severe renal impairment (creatinine clearance below 30 mL/min), or ongoing long-term dialysis.
  • Severe cardiovascular or cerebrovascular disease, including myocardial infarction, cardiac arrest, decompensated heart failure, significant arrhythmias (such as second-degree or higher atrioventricular block without a pacemaker), congenital heart disease, severe valvular disease, extensive cerebral hemorrhage, or cerebral infarction; or significant respiratory disease, including a history of asthma, acute exacerbation of chronic obstructive pulmonary disease, or previous pulmonary resection.
  • History of long-term opioid use before surgery or chronic pain.
  • Pregnancy or breastfeeding.
  • Other severe medical conditions or psychiatric disorders that make participation in the study unsuitable.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Low-Dose Tegileridine

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.07 mg/kg.
Droga: Tegileridine

Tegileridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery. The prescribed dose is 0.07 mg/kg in the low-dose group and 0.11 mg/kg in the high-dose group. Participants receive only their assigned dose regimen.
Sperimentale: High-Dose Tegileridine

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.11 mg/kg.
Droga: Tegileridine

Tegileridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery. The prescribed dose is 0.07 mg/kg in the low-dose group and 0.11 mg/kg in the high-dose group. Participants receive only their assigned dose regimen.
Sperimentale: Oliceridine

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with oliceridine at a prescribed dose of 0.36 mg/kg.
Droga: Oliceridine

Oliceridine is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 0.36 mg/kg.
Sperimentale: Sufentanil

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with sufentanil at a prescribed dose of 2.0 micrograms/kg.
Droga: Sufentanil

Sufentanil is administered by patient-controlled intravenous analgesia (PCIA) after gynecologic laparoscopic surgery at a prescribed dose of 2.0 micrograms/kg. This group serves as the active comparator.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to Gastrointestinal Recovery (GI-2)
Lasso di tempo: From the end of surgery up to 7 days postoperatively.

GI-2 is defined as the time from the end of surgery until both the first bowel movement (defecation) and tolerance of solid food have occurred. The later of these two events determines the GI-2 recovery time, measured in hours. Participants who do not achieve GI-2 within 7 days will be recorded as not having reached the endpoint during the follow-up period.
From the end of surgery up to 7 days postoperatively.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Passage of Flatus
Lasso di tempo: From the end of surgery up to 7 days postoperatively.

Time from the end of surgery to the first passage of flatus, measured in hours. A shorter time indicates earlier recovery of postoperative bowel function.
From the end of surgery up to 7 days postoperatively.
Postoperative Gastrointestinal Function (I-FEED Score)
Lasso di tempo: At 6, 24, and 48 hours postoperatively.

Gastrointestinal function assessed using the I-FEED score at each scheduled postoperative assessment. The protocol describes a score ranging from 0 to 10, with higher scores indicating worse gastrointestinal function.
At 6, 24, and 48 hours postoperatively.
Postoperative Pain Intensity (VAS Score)
Lasso di tempo: At 6, 24, and 48 hours postoperatively.

Postoperative pain intensity assessed using a 0-to-10 Visual Analog Scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores are recorded at each scheduled assessment.
At 6, 24, and 48 hours postoperatively.
Incidence of Postoperative Nausea and Vomiting
Lasso di tempo: Within 48 hours postoperatively.

Percentage of participants experiencing at least one episode of nausea or vomiting within 48 hours after surgery.
Within 48 hours postoperatively.
Small Bowel Peristaltic Frequency
Lasso di tempo: At 6, 24, and 48 hours postoperatively.

Frequency of small bowel peristaltic movements assessed by ultrasonography, expressed as contractions per minute.
At 6, 24, and 48 hours postoperatively.
Incidence of Opioid-Related Adverse Reactions
Lasso di tempo: Within 48 hours postoperatively.

Percentage of participants experiencing at least one opioid-related adverse reaction, including dizziness, somnolence, respiratory depression, pruritus, abdominal distension, or constipation, within 48 hours after surgery.
Within 48 hours postoperatively.
Number of Patient-Controlled Analgesia Button Presses
Lasso di tempo: Within 48 hours postoperatively.

Total number of patient-initiated button presses recorded by the patient-controlled intravenous analgesia pump during the first 48 hours after surgery.
Within 48 hours postoperatively.
Number of Rescue Analgesia Administrations
Lasso di tempo: Within 48 hours postoperatively.

Total number of rescue analgesic administrations received by each participant within 48 hours after surgery.
Within 48 hours postoperatively.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hainan Medical College

Collaboratori

The Second Affiliated Hospital of Hainan Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

20 dicembre 2026

Completamento dello studio (Stimato)

25 dicembre 2026

Date di iscrizione allo studio

Primo inviato

3 novembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 novembre 2026

Primo Inserito (Effettivo)

9 novembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-K51-01

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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