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临床试验/NCT04411069
NCT04411069已完成2 期

Simplified Algorithm for the Prevention of Postoperative Nausea and Vomiting in an Oncological Hospital

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2019年2月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
270
试验地点
1
主要终点
postoperative nausea and vomiting

研究概览

简要总结

Previous history of nausea and vomiting induced by prior chemotherapy still not included as predictive factor of postoperative nausea and vomiting, although has been demonstrated that has influence in postoperative outcome.

The project aims to evaluate the efficacy of a simplified algorithm in prevention postoperative nausea and vomiting , with pacients with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium or large surgery.

详细描述

Quasi-experimental study, with evaluation after the application of a specific postoperative nausea and vomiting prevention algorithm for cancer patients.

The study will be carried out in 2 phases:

Phase 1: Team training. In this phase, a protocol was established for PONV prophylaxis, using two questions:

  1. Patient undergoing chemotherapy before surgery;
  2. Patient presented chemotherapy induced nausea and vomiting (CINV).

If the answer is yes to both questions, the anesthetist administers 3 antiemetics (4mg dexametasone, 4mg ondansetron and 0,625mg droperidol). If the answer is no to one of the questions, the anesthetist administers 2 antiemetics (4mg dexametasone and 4mg ondansetron); In this phase, educational measures will be implemented by team meetings and individual approach of all anesthesiologists at ICESP to present the study project and the algorithm. A summary of the the study will be sent daily through the social network Whats App®.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

盲法说明

The patient didn't know if he received the third anti emetic

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients who underwent medium to large surgery

排除标准

  • Patients who are unable to communicate (orotracheal intubation after the surgery, confusion or agitation) or understand the Portuguese language;
  • Insulin dependent patients
  • Patients who underwent emergency surgery and neurosurgery
  • Pacients who had an increased QT interval on the electrocardiogram
  • History of allergy to dexametasone, ondansetron or droperidol
  • Refusal to participate

研究组 & 干预措施

Patients with previous CINV

Other

Patients who had previous nausea and vomiting induced by chemoterapy.

干预措施: Droperidol (Drug)

结局指标

主要结局

postoperative nausea and vomiting

时间窗: from 0 to 24 postoperative hours

record of any episode of nausea and or vomiting in the 24 postoperative hours

次要结局

  • Changing in the institutional protocol(from the begining to the study to the end of the study (2 years))

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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