跳至主要内容
临床试验/CTRI/2024/08/072352
CTRI/2024/08/072352尚未招募Unknown

Efficacy of a restrictive anti-emetic strategy in patients with low risk of postoperative nausea and vomiting (PONV)- A randomised control trial

Dr Chandramma Dayananda Sagar Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 640 人开始时间: 2024年8月26日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方
入组人数
640
试验地点
1
主要终点
Incidence of PONV in both groups in first 24 hours after surgery.

研究概览

简要总结

 Nausea and vomiting are one of the most frequently encountered symptoms in patients who have undergone a surgery.They can be especially distressing to the patient and hamper a speedy recovery, more so in case of day care procedures.  Post operative Nausea and Vomiting or PONV as it is frequently referred to as, is a very important factor in the overall patient satisfaction in the hospital.The estimated incidence of PONV is around 30% in the overall surgical population and can be as high as 80% in high risk cohorts.The occurrence of PONV is also associated with increased length of PACU stay and increased health care costs.Hence, reducing the incidence of PONV should be a constant strife for the anaesthesiologist.

 The risk factors for an increased risk of PONV can be classified as patient factors like female sex, young age, non -smokers and a history of motion sickness/PONV and procedural factors like duration of anaesthesia, use of inhalational anaesthetics and nitrous oxide, General anaesthesia and use of post operative opioids.

 Apfel and colleagues devised a scoring system to risk stratify patients as high or low risk for PONV. The ‘Apfel Score’ includes female gender, non-smoker, history of PONV or motion sickness and post operative use of opioids, with a higher score meaning a higher chance of the patient experiencing PONV. Koivuranta score includes the risk factors of Apfel score along with duration of surgery > 60 minutes.

 The fourth consensus guidelines for the prevention and management of PONV was published in 2020 under the auspices of the American Society of Enhanced Recovery and Society for Ambulatory Anaesthesia. This is a comprehensive document for a clinician to practice in the perioperative arena. As per the consensus guidelines a multimodal therapy is advocated in patients to prevent PONV, with two different classes of anti-emetics in low risk and three or more different classes of anti-emetics in case of high risk patients.

 According to the fourth consensus guidelines for the management of PONV ‘there are very few studies directly comparing the efficacy of a risk-based “restrictive” antiemetic prophylaxis approach to a more liberal multimodal antiemetic prophylaxis approach’

They also state that direct comparisons of different combination therapies of anti-emetics is lacking and any evidence in that regard would prove invaluable.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • patients with APFEL score 2or less preoperatively
  • duration of surgery less than 60 minutes
  • surgeries under spinal/regional/ local anaesthesia.

排除标准

  • surgeries with high risk of PONV like middle ear surgeries, laparotomy.

结局指标

主要结局

Incidence of PONV in both groups in first 24 hours after surgery.

时间窗: 1) patients will be monitored for 24 hrs after surgery . | 2)duration of study is 1 year

次要结局

  • Need for rescue antiemetics in 24 hours(1) patients will be monitored for 24 hrs after surgery .)

研究者

发起方
Dr Chandramma Dayananda Sagar Institute of Medical Education and Research
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

DR CHAITRA V

Dr Chandramma Dayanand Sagar Institute of Medical Science & Research

研究点 (1)

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