NCT07713134已完成不适用
Efficacy and Safety of the Biased μ-Opioid Receptor Agonist Oliceridine in Hysteroscopic Procedures
Tangshan Maternal and Child Health Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2025年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- heart rate（beats per minute）
研究概览
简要总结
This study aimed to investigate the safety and efficacy of oliceridine compared with sufentanil in outpatient hysteroscopy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •voluntary signing of the anesthesia informed consent form;
- •stable vital signs;
- •age between 18 and 60years;
- •American Society of Anesthesiologists (ASA) physical status I or II; and
- •body mass index (BMI) <30 kg/m²
排除标准
- •inability or unwillingness to sign the informed consent form;
- •known allergy to the study drug;
- •uncontrolled hypertension or diabetes mellitus;
- •significant central nervous system disease;
- •diagnosed psychiatric disorders;
- •use of anxiolytics, antidepressants, hypnotics, or sedatives within the past three months
结局指标
主要结局
heart rate（beats per minute）
时间窗: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery
mean arterial pressure(mmHg)
时间窗: before anesthesia induction (baseline), immediately after induction of anesthesia, and at the end of surgery
proportion of participants with successful completion of office hysteroscopy procedure
时间窗: at the end of the hysteroscopy procedure
次要结局
- number of participants with postoperative nausea and vomiting within 24 hours after surgery(within 24 hours after surgery)
- number of Participants with Intraoperative Respiratory Depression(from induction of anesthesia to completion of surgery)
研究者
Yu Zhang
principle investigator
Tangshan Maternal and Child Health Hospital
研究点 (1)
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