Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery (TASPER)
2026년 6월 4일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
84
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Jihong Jiang, MD
- 전화번호: 86-13482002227
- 이메일: jiangjihong@outlook.com
연구 연락처 백업
- 이름: Jie Xiao
- 전화번호: 86-18353689295
- 이메일: XiaoJie20220747@163.com
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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Tegileridine 5 mg will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
|
|
활성 비교기: 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.
|
Palonosetron 0.5 mg will be included in the postoperative patient-controlled intravenous analgesia solution in both study groups for antiemetic prophylaxis.
Sufentanil 100 micrograms will be administered as part of postoperative patient-controlled intravenous analgesia after major laparoscopic abdominal surgery.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
기간: 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.
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From 0 to 24 hours after admission to the PACU
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Resting and Movement Pain Intensity
기간: At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
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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.
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At 0, 0.5, 6, 12, 18, 24, 48, and 72 hours after admission to the PACU
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PCIA Demand and Effective Press Counts
기간: Within 48 hours after admission to the PACU.
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Total PCIA demand counts and effective press counts recorded within 48 hours after admission to the PACU.
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Within 48 hours after admission to the PACU.
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Use of Rescue Analgesia
기간: Within 72 hours after admission to the PACU
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The dose and frequency of rescue analgesic medications, including additional opioid analgesics, will be recorded within 72 hours after admission to the PACU.
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Within 72 hours after admission to the PACU
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Incidence and Severity of PONV
기간: Within 72 hours after admission to the PACU
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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.
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Within 72 hours after admission to the PACU
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Time to First Flatus
기간: From admission to the PACU until first passage of flatus, assessed up to 1 week.
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Time to first flatus will be defined as the time from admission to the PACU to the first passage of flatus.
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From admission to the PACU until first passage of flatus, assessed up to 1 week.
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Time to First Bowel Movement
기간: From admission to the PACU until first bowel movement, assessed up to 1 week.
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Time to first bowel movement will be defined as the time from admission to the PACU to the first postoperative bowel movement.
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From admission to the PACU until first bowel movement, assessed up to 1 week.
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Time to Resumption of Oral Intake
기간: From admission to the PACU until resumption of oral intake, assessed up to 1 week.
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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.
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From admission to the PACU until resumption of oral intake, assessed up to 1 week.
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Length of Postoperative Hospital Stay
기간: From admission to the PACU until hospital discharge, assessed up to 30 days.
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Length of postoperative hospital stay will be defined as the number of days from the day of surgery to hospital discharge.
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From admission to the PACU until hospital discharge, assessed up to 30 days.
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Changes in Inflammatory Biomarkers
기간: Before surgery and at predefined time points within 72 hours after admission to the PACU
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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.
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Before surgery and at predefined time points within 72 hours after admission to the PACU
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Changes in I-FABP
기간: Before surgery and at predefined time points within 72 hours after admission to the PACU
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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.
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Before surgery and at predefined time points within 72 hours after admission to the PACU
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 1일
기본 완료 (추정된)
2027년 1월 1일
연구 완료 (추정된)
2027년 6월 1일
연구 등록 날짜
최초 제출
2026년 4월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 4일
처음 게시됨 (실제)
2026년 6월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 10일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 4일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IIT-CRU-FAMB-2026HS100
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.
약물 및 장치 정보, 연구 문서
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