The Effect of Oliceridine on Gastrointestinal Dysfunction and Pain Management in Patients Undergoing Neurosurgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 176
- 主要终点
- High risk rate of gastrointestinal dysfunction
研究概览
简要总结
Gastrointestinal dysfunction is common in patients after major surgery, especially for neurosurgery. It was reported 80% of neurosurgery patients could be combined with gastrointestinal dysfunction, and it may relate to old age, surgery time, and factors of anesthesia and surgery. Meanwhile, postoperative constipation, nausea, and vomiting induced by gastrointestinal dysfunction may increase the intracranial bleeding. Oliceridine could activate mu opioid receptors without the interaction of (beta)arr2-muOR, and may reduce the gastrointestinal dysfunction, but a limited study has illustrated this topic. Thus, this study is conducted to explore whether oliceridine could reduce the gastrointestinal dysfunction vs. sufentanil in patients undergoing neurosurgery.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing selective neurosurgical resection of craniocerebral tumors;
- •Age ≥ 18 years old;
- •American Society of Anesthesiologists (ASA) grade 1-3;
- •Sign the informed consent form.
排除标准
- •Patients unable to complete scale assessment due to preoperative language dysfunction or communication impairment;
- •Patients with preoperative symptoms of posterior cranial nerve injury and who need to retain a tracheal tube;
- •Patients with insular, brainstem, or medullary lesions that may impair early postoperative recovery of consciousness;
- •Patients undergoing intracranial lesion resection via the transsphenoidal approach;
- •Patients with a history of previous abdominal surgery;
- •Patients with BMI > 35.0 kg/m2;
- •Patients with liver or kidney dysfunction;
- •Patients with a history of allergic or adverse reactions to the test drug;
- •Patients with a history of drug abuse;
- •Pregnant or lactating women.
研究组 & 干预措施
Oliceridine group
干预措施: Experimental: Oliceridine group (Drug)
Classical opioid group
干预措施: Active Comparator: Classical opioid group (Drug)
结局指标
主要结局
High risk rate of gastrointestinal dysfunction
时间窗: Within 72 hours after the operation
The high-risk rate of postoperative gastrointestinal dysfunction was assessed using the Intake, feeling nauseated, emesis, physical examination, and duration of symptoms (I-FEED) scoring system.
次要结局
未报告次要终点
研究者
Ruquan Han
Head of Anesthesiology
Beijing Tiantan Hospital