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

2026年11月3日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

212

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Hainan
      • Haikou、Hainan、中国、571199
        • 招聘中
        • The Second Affiliated Hospital of Hainan Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：Low-Dose Tegileridine

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.07 mg/kg.
药品：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.
实验性的：High-Dose Tegileridine

Participants receive postoperative patient-controlled intravenous analgesia (PCIA) with tegileridine at a prescribed dose of 0.11 mg/kg.
药品：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.
实验性的：Oliceridine

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

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

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

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to Gastrointestinal Recovery (GI-2)
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Time to First Passage of Flatus
大体时间：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)
大体时间：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)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：Within 48 hours postoperatively.

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hainan Medical College

合作者

The Second Affiliated Hospital of Hainan Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年6月1日

初级完成 (估计的)

2026年12月20日

研究完成 (估计的)

2026年12月25日

研究注册日期

首次提交

2026年11月3日

首先提交符合 QC 标准的

2026年11月3日

首次发布 (实际的)

2026年11月9日

研究记录更新

最后更新发布 (实际的)

2026年11月9日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-K51-01

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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