2025-522529-36-00招募中3 期
Postoperative recovery with the addition of long-acting NK1- and 5-HT3 receptor antagonists as prophylaxis for post-operative nausea and vomiting. A prospective, double-blind, randomized trial in laparoscopic surgery.
Region Vaesternorrland, Umea University3 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年12月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 220
- 试验地点
- 3
- 主要终点
- QoR-15swe scores preoperative (baseline) and on POD1
研究概览
简要总结
Is the reduction in QoR-15swe from baseline before surgery to the first postoperative day (POD 1) at least 8.0 points smaller in the intervention group compared to the control group?
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •The subject has given their written consent to participate in the trial
- •Adult male or female subjects (>=18 years old)
- •ASA-class I-III
- •Scheduled for elective laparoscopic bariatric surgery or laparoscopic cholecystectomies under general anesthesia
- •Women of Childbearing Capacity (WOCBC) only if pregnancy test is negative or if the woman is using highly effective contraception methods
排除标准
- •Not able to understand and/or cooperative with the study protocol.
- •Documented allergy or intolerance to the IMPs.
- •Psychiatric condition or other reasons that jeopardize compliance with follow up.
- •Breast-feeding females
- •Intestinal obstruction, accessed by anamnesis or clinical findings.
- •Immunosuppressive treatment.
- •Medication with SSRI or SNRI.
- •Female subjects using anticontraceptive drugs not accepting the need for alternative contraceptive methods for two months (if anticonception is desired by the subject).
结局指标
主要结局
QoR-15swe scores preoperative (baseline) and on POD1
QoR-15swe scores preoperative (baseline) and on POD1
次要结局
- QoR-15swe on POD0, POD2 and POD3
- Events of nausea or vomiting at PACU, at the hospital and at home up to POD3.
- Use of antiemetics at PACU, at the hospital and at home up to POD3.
- Pain assessments (NRS) at PACU, during hospital stay and at home up to POD3.
- Time at PACU
- Time at hospital until discharge.
- Events of known side-effect of IMP such as infusion-site reactions, headache, visual disturbances, constipation, diarrhoea and tiredness.
- Complications from POD0 to POD 30 according to Clavien-Dindo
- Themes from qualitative interviews of patient experiences on postoperative recovery using inductive thematic analysis (30-90 days after first visit)
研究者
Jakob Walldén
Scientific
Region Vaesternorrland
研究点 (3)
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