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Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

2026年9月2日 更新者：Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial

A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.

研究の種類

介入

入学 (推定)

117

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

研究場所

  • 中国
    • Guangdong
      • Guangzhou、Guangdong、中国、510000
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • コンタクト：

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:

  • Aged ≥ 18 years;
  • American Society of Anesthesiologists (ASA) physical status classification I-III;
  • Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
  • Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
  • Agree to participate in this trial and voluntarily sign the informed consent form.

Exclusion Criteria:

  • Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
  • Patients undergoing emergency surgery or trauma patients;
  • Intraoperative conversion to open laparotomy;
  • History of abdominal surgery within the past 3 months;
  • Patients undergoing liver transplantation or with metastasis to other organs;
  • Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
  • Severe renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²);
  • Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
  • Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
  • Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
  • Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
  • Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
  • Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.

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：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：Anruikefon 1 μg/kg per dose Group
Anruikefon 1 μg/kg per dose, once every 8 hours (q8h), for a total of 6 doses.
薬：Anruikefon 1 μg/kg per dose Group
Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
実験的：Anruikefon 100 μg per dose Group
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
薬：Anruikefon 100 μg per dose Group
Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
プラセボコンパレーター：Placebo Group
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
薬：Control group
0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

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
時間枠
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration
時間枠：0-48 hours post first study drug dose
0-48 hours post first study drug dose

二次結果の測定

結果測定
時間枠
Proportion of rescue analgesia
時間枠：Within0-24 hours and 0-48 hours after the first study drug administration
Within0-24 hours and 0-48 hours after the first study drug administration
Cumulative consumption dose of rescue analgesia
時間枠：within 0-24 hours and 0-48 hours after the first study drug administration
within 0-24 hours and 0-48 hours after the first study drug administration
Time from end of surgery to first passage of flatus (hours)
時間枠：Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first flatus occurs
Time from end of surgery to first defecation (hours)
時間枠：Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first defecation occurs
Time from the end of surgery to first ambulation (hours)
時間枠：Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Throughout the inpatient hospital stay after surgery, from the end of surgery until the first ambulation occurs
Incidence of nausea, vomiting and PONV
時間枠：Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Patient satisfaction score for analgesia
時間枠：Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Proportion of subjects with resting numerical rating scale (NRS) pain score ≥ 3
時間枠：Within 0-24 hours and 0-48 hours after the first study drug administration
Within 0-24 hours and 0-48 hours after the first study drug administration
Resting numerical rating scale (NRS) pain score
時間枠：At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Movement-evoked numerical rating scale (NRS) pain score
時間枠：At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
At 1 hour (±30 minutes), 8 hours (±2 hours), 24 hours (±2 hours), 48 hours (±3 hours) after the first study-drug administration
Incidence of rescue antiemetic treatment
時間枠：Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Cumulative dose of rescue antiemetic treatment
時間枠：Within 48 hours after the first study drug administration
Within 48 hours after the first study drug administration
Incidence of serious adverse events and study drug-related adverse events
時間枠：Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Throughout the inpatient hospital stay after surgery, from the end of surgery until hospital discharge
Sleep quality score assessed using the Richards-Campbell Sleep Questionnaire (RCSQ; score range 0-100, higher scores indicate better sleep quality)
時間枠：On the single night following the first administration of study drug
On the single night following the first administration of study drug
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
時間枠：Within 24 hours after the first study-drug administration
Within 24 hours after the first study-drug administration
Serum biomarker concentrations: alanine transaminase (ALT), aspartate transaminase (AST), albumin (ALB), total bilirubin (TBIL), direct bilirubin (DBIL), indirect bilirubin (IBIL), international normalized ratio (INR)
時間枠：Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Preoperative baseline (prior to surgical incision), and within the interval from 24 hours to 48 hours after the first administration of study drug
Proportion of subjects with movement-evoked Numerical Rating Scale (NRS) pain score ≥ 3
時間枠：Within 0-24 hours and 0-48 hours after the first study-drug administration
Within 0-24 hours and 0-48 hours after the first study-drug administration
Overall patient recovery quality score evaluated via the QoR-15 questionnaire (score range 0-150; higher scores indicate better recovery quality)
時間枠：Within 48 hours after the first study-drug administration
Within 48 hours after the first study-drug administration
Cumulative opioid consumption, converted to intravenous morphine milligram equivalents (MME)
時間枠：Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug
Within the interval from 0 hours to 24 hours after the first administration of study drug, and within the interval from 0 hours to 48 hours after the first administration of study drug

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。

スポンサー

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

捜査官

  • 主任研究者：Changzhen Shang、Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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8月30日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年7月30日

試験登録日

最初に提出

2026年7月29日

QC基準を満たした最初の提出物

2026年9月2日

最初の投稿 (実際)

2026年9月3日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月3日

QC基準を満たした最後の更新が送信されました

2026年9月2日

最終確認日

2026年7月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • SYSKY-2026-307-03

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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