Determination of the Effective Dose of a Single Intravenous Dose of Tegileridine Fumarate for Postoperative Analgesia After Orthopedic Surgery: A Up-and-Down Sequential Allocation Study

Обзор

The goal of this clinical trial is to determine the 90% effective dose (ED90) of a single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients aged 18-75 years with American Society of Anesthesiologists (ASA) physical status I-III undergoing orthopedic surgery, including spinal fusion surgery, femoral fracture fixation, and total knee arthroplasty. The main questions this study aims to answer are: What is the ED90 of a single intravenous dose of tegileridine fumarate for achieving adequate postoperative analgesia, defined as a Numeric Rating Scale (NRS) pain score ≤ 3 within 30 minutes after awakening from anesthesia without the need for rescue analgesia? Participants will: Receive a single intravenous injection of tegileridine fumarate during skin closure at the end of surgery. Start with an initial dose of 0.5 mg, with subsequent doses adjusted upward or downward in 0.1 mg increments for the next participant based on the analgesic response of the preceding participant, following a biased-coin up-and-down sequential dose allocation design. Be closely monitored during the postoperative recovery period for pain intensity, vital signs (including heart rate, blood pressure, respiratory rate, and oxygen saturation), and adverse reactions such as nausea, vomiting, respiratory depression, agitation, and other opioid-related side effects. This study aims to identify an optimal single-dose regimen of tegileridine fumarate that provides effective postoperative analgesia with an acceptable safety profile, thereby improving postoperative pain control and promoting enhanced recovery in patients undergoing orthopedic surgery.

Вмешательства

• Препарат Single intravenous injection of Tegileridine Fumarate
  Single intravenous injection of tegileridine fumarate for postoperative analgesia in adult patients (18-75 years, ASA I-III) undergoing orthopedic surgery, including spinal fusion, femoral fracture fixation, and total knee arthroplasty. The study uses a dose-escalation design to determine the 90% effective dose (ED90). Doses: To be determined using an up-and-down sequential allocation method (dose-ranging study).

Первичные конечные точки

• Effective dose producing adequate postoperative analgesia in 90% of patients (ED90) [Срок оценки: Within 30 minutes after awakening from anesthesia]

Вторичные конечные точки (9)

• Incidence and severity of postoperative nausea and vomiting (PONV) [Срок оценки: From drug administration to 24 hours postoperatively]
• Heart rate (HR) [Срок оценки: From immediately before drug administration to 24 hours postoperatively]
• Respiratory Rate (RR) [Срок оценки: From immediately before drug administration to 24 hours postoperatively]
• Peripheral Oxygen Saturation (SpO₂) [Срок оценки: From immediately before drug administration to 24 hours postoperatively]
• Extubation-related airway responses [Срок оценки: From extubation until 10 minutes after extubation]
• Postoperative rescue analgesia requirement [Срок оценки: From awakening to 24 hours postoperatively]
• Patient-controlled analgesia (PCA) usage [Срок оценки: From awakening to 24 hours postoperatively]
• Postoperative pain intensity (NRS scores) [Срок оценки: 30 minutes, 6 hours, 12 hours, and 24 hours after awakening]
• Incidence of postoperative adverse events [Срок оценки: From drug administration to 24 hours postoperatively]

Критерии участия

Критерии включения

• Adults aged 18 to 75 years.
• Scheduled for elective orthopedic surgery, including spinal fusion, femoral fracture fixation, or total knee arthroplasty.
• American Society of Anesthesiologists (ASA) physical status I-III.
• Ability to understand the study procedures and provide written informed consent.

Критерии исключения

• Patients with moderate to severe obesity (BMI > 30 kg/m²).
• Known hypersensitivity or allergy to tegileridine fumarate or other analgesics.
• History of chronic pain or long-term use of opioids.
• Severe hepatic or renal impairment.
• Patients requiring postoperative ICU care.
• Severe respiratory depression (e.g., oxygen saturation < 90%).
• Known or suspected gastrointestinal obstruction, including paralytic ileus.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The Second Affiliated Hospital of Zhejiang University anesthesiology department — Hanzhong

Идентификаторы

NCT: NCT07353996 · 2025-0393

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗