Tegileridine vs Sufentanil for Postoperative Pain Management and Gastrointestinal Recovery After Major Laparoscopic Abdominal Surgery (TASPER)
2026年6月4日 更新者：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.
調査の概要
研究の種類
介入
入学 (推定)
84
段階
- フェーズ 4
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jihong Jiang, MD
- 電話番号：86-13482002227
- メール：jiangjihong@outlook.com
研究連絡先のバックアップ
- 名前：Jie Xiao
- 電話番号：86-18353689295
- メール：XiaoJie20220747@163.com
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
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.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Area Under the Curve of Resting Pain Intensity Within 24 Hours After Admission to the PACU
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Resting and Movement Pain Intensity
時間枠：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
時間枠：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.
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Within 48 hours after admission to the PACU.
|
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Use of Rescue Analgesia
時間枠：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
時間枠：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.
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Within 72 hours after admission to the PACU
|
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Time to First Flatus
時間枠：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.
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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
時間枠：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
時間枠：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.
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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
時間枠：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.
|
From admission to the PACU until hospital discharge, assessed up to 30 days.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in Inflammatory Biomarkers
時間枠：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.
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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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月1日
一次修了 (推定)
2027年1月1日
研究の完了 (推定)
2027年6月1日
試験登録日
最初に提出
2026年4月29日
QC基準を満たした最初の提出物
2026年6月4日
最初の投稿 (実際)
2026年6月10日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月10日
QC基準を満たした最後の更新が送信されました
2026年6月4日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IIT-CRU-FAMB-2026HS100
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
Individual participant data will not be shared because of participant privacy protection and institutional data management requirements.
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