NCT06458400已完成4 期
To Evaluate the Efficacy and Safety of Tegileridine and Oliceridine Injections in the Treatment of Postoperative Pain
Yuwei Qiu1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2024年7月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
研究概览
简要总结
This was a single-center, randomized, open-label, controlled exploratory study conducted in Chinese patients. The study planned to enroll Chinese patients to evaluate the efficacy and safety of tegileridine and oliceridine injection in the treatment of postoperative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Accept elective laparoscopic combined thoracic surgery under general anesthesia, surgery time ≥ 1 h;
- •18 years old ≤ age ≤70 years old, regardless of gender;
- •18 kg/m2≤BMI≤30 kg/m2;
- •American Society of Anesthesiologists (ASA) grade ⅰ-ⅲ;
- •Within 4 hours after the end of surgery, NRS≥4 in the resting state at any time;
- •Before starting trial-related activities, participants should voluntarily sign the informed consent form, fully understand the purpose and significance of this trial, and voluntarily abide by the trial procedures.
排除标准
- •Patients with a previous history of difficult airway (obstructive sleep apnea syndrome), severe respiratory depression such as oxygen saturation < 90%, or a history of acute or severe bronchial asthma;
- •Patients with a history of severe cardiovascular and cerebrovascular diseases (such as myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree Ⅱ or above, or ischemic stroke in NYHA class Ⅱ or above);
- •Known or suspected gastric bowel obstruction, including paralytic ileus patients;
- •Patients with allergy to opioids or any component of the trial drug;
- •Subjects with previous psychiatric disorders (such as schizophrenia, depression, etc.) and cognitive impairment;
- •With late-stage malignant tumors or with extensive metastasis of malignant tumor patients;
- •Subjects with other somatic pain that may affect postoperative pain assessment;
- •A history of drug, drug, and/or alcohol abuse within 1 year before randomization;
- •Pregnant or lactating female subjects;
- •Subjects with any other factor considered by the investigator to be ineligible for participation in the trial.
研究组 & 干预措施
tegileridine
Experimental
The loading iv dose: 0.75mg The PCIA dose：0.05mg Lockout time: 10min
干预措施: Tegileridine (Drug)
oliceridine
Experimental
The loading iv dose: 1.5mg The PCIA dose：0.35mg Lockout time: 6min
干预措施: Oliceridine (Drug)
morphine
Active Comparator
The loading iv dose: 3mg The PCIA dose：1mg Lockout time: 6min
干预措施: Morphine (Drug)
结局指标
主要结局
Time-weighted sum of differences of resting pain score within 24 hours after starting a loading dose of test drug infusion
时间窗: during the first 24 hours after starting a loading dose of test drug infusion
"resting pain score" is assessed by Numeric Rating Scale, range 0-10, 0=no pain and 10 = worst imaginable pain, from 0 to 0 means worse pain
次要结局
- total doses of postoperative analgesic pump(the first 24 hours after surgery)
- Resting-state pain and exercise-state pain intensity(Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose)
- Time-weighted sum of differences of exercise-state pain score within 24 hours after starting a loading dose of test drug infusion(Pain scores are evaluated at 10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose)
- incidence rate of respiratory depression(the first 24 hours after surgery)
- total pain relief (TOTPAR) scores(10 minutes、30 minutes、6 hours、12 hours、24 hours after the first loading dose)
- pressing times of postoperative analgesic pump(the first 24 hours after surgery)
- the percentage of patients receiving rescue analgesia(from 0-24 hours after the first loading dose)
- length of bed stay(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.)
- Length of hospital stay(From date of randomization until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 1 months.)
- incidence of Postoperative nausea and vomiting(the first 24 hours after surgery)
- analgesia satisfaction(the first 24 hours after surgery)
研究者
Yuwei Qiu
Associate chief physician, Associate director of anesthesiology, Associate professor
Shanghai Chest Hospital
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Teneligliptin in Chinese Patients With Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT02916706Tanabe Pharma Corporation254
Unknown
不适用
Arsenic Trioxide in Recurrent and Metastatic Ovarian Cancer and Endometrial Cancer With P53 MutationEndometrial CancerOvarian CancerNCT04489706Ruijin Hospital20
已完成
不适用
Evaluation of the TECNIS Symfony® Toric Intraocular LensCataractsNCT05053399Johnson & Johnson Surgical Vision, Inc.82
招募中
2 期
A Study to Evaluate Tislelizumab Combined With Sitravatinib as Adjuvant Therapy in Participants With HCC at High Risk of Recurrence After Curative ResectionHepatocellular CarcinomaNCT05407519Anhui Provincial Hospital40
进行中（未招募）
3 期
Study of Atezolizumab Plus Carboplatin and Etoposide With or Without Tiragolumab in Participants With Untreated Extensive-Stage Small Cell Lung CancerSmall Cell Lung CarcinomaNCT04665856Hoffmann-La Roche123