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临床试验/NCT03201315
NCT03201315已完成不适用

The Incremental Risk of Intraoperative Fentanyl on PONV: A Modifiable Risk Without Drawbacks?

University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 363 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
363
试验地点
1
主要终点
Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery

研究概览

简要总结

The aim of this quality control study is to describe the presence and intensity of postoperative nausea and vomiting (PONV) and its correlation with intraoperative fentanyl dosing. Additionally, the investigators will examine pain scores.

详细描述

The primary aims of this quality control study are:

  1. to determine whether there is an independent association between the intraoperative administration of fentanyl (both as a continuous and categorical variable) and PONV within 24 postoperative hours
  2. determine whether or not the intraoperative fentanyl amount can be used to successfully restratify patients for PONV beyond the simplified Apfel score for PONV

All required data is collected in regular daily practice. The following variables will be assessed by univariable models:

Preoperative variables (e.g. patient characteristics) Surgical/Anesthesia variables (e.g. type/length of surgery, antiemetics) Outcome variables (PONV, worst pain as delineated in the outcomes section), Intraoperative fentanyl measured 1) as a continuous variable and 2) by predefined limits of 0 to 0.2mg, >0.2-0.5mg, >0.5 to 0.8mg, and >8mg.

Finally for the multivariable model, the investigators will adjust for confounders, specifically for sex (m/f), history (Hx) of PONV (y/n), Hx of motion sickness (y/n), current smoker (y/n), age (years), expected duration of surgery (min; >60 min), postoperative opioids (y/n), the use of preemptive PONV Therapy (0,1,2 medications), propofol vs. inhalative agents (y/n), and surgery type (3 kinds) from the patient's electronic record. In the event that insufficient event rates are observed, we will collapse the variables into the simplified Apfel score to assess the independent value of fentanyl in predicting PONV.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • In-patients with an expected simplified Apfel score of 2 or higher,
  • Aged >= 18 years, and
  • Undergoing general anesthesia (with or without neuraxial or regional anesthesia.)
  • in abdominal, gynecological or otorhinolaryngological surgery

排除标准

  • Outpatients
  • Patients with chronic pain, defined as recurring pain requiring intermittent hospitalization or regular intake of pain medication.
  • Non-opioid naïve patients, defined as a history of abuse or having taken opioids within the last 30 days

结局指标

主要结局

Any postoperative nausea and/or vomiting (PONV) within 24 hours after surgery

时间窗: within 24 hours (or next morning discharge)

postoperative nausea and/or vomiting (PONV) yes/no (either by chart or by patient confirmation) within 24 hours (or next morning discharge)

次要结局

  • number of postoperative vomiting events within 24 hours(within 24 hours (or next morning discharge))
  • Any postoperative nausea and/or vomiting (PONV) while in the recovery room(first two postoperative hours)
  • Worst pain, i.e. highest Numeric Rating Score (NRS)(within 24 hours / in recovery room (first two postoperative hours))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (1)

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