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临床试验/NCT05141591
NCT05141591招募中不适用

The Impact of Gender-specific Preoperative Anxiety Level on Postoperative Opioid Requirement After ENT Surgery.

Medical University of Vienna1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年11月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Opioid consumption

研究概览

简要总结

The study will be designed to investigate the impact of the preoperative anxiety level on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

详细描述

Background Due to the frequency of surgeries, acute postsurgical pain (APSP) is a common clinical problem. In this study, the investigators will investigate pre-surgical psychological factors associated with the experience of APSP in ENT surgery.

The study will be designed to investigate the impact of gender-specific preoperative anxiety states, using the STOA, APAIS, PCS and VAS-A scoring systems, on postoperative opioid consumption after elective ENT surgery.

These findings may have important implications for developing more personalized strategies in acute postoperative pain therapy in selected patients.

Aim Study aim is to investigate the impact of the preoperative anxiety level, using the validated STOA questionnaire, on postoperative opioid requirement during the PACU stay, in order to improve postoperative pain treatment in the long term after ENT surgery.

The present study can contribute to improve postoperative pain management in patients in the field of ENT surgery, as new influencing parameters and risk factors may be discovered.

研究设计

研究类型
Observational
观察模型
Other
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

  • American Society of Anesthesiology (ASA) physical status I-IV
  • able to read and understand the information sheet and to sign the consent form
  • being scheduled for elective ENT surgery under general anesthesia
  • written informed consent
  • age≥18 years

排除标准

  • difficulty to understand study procedure, pain scoring system or questionnaires
  • surgical procedure warranting elective postoperative ventilation

结局指标

主要结局

Opioid consumption

时间窗: during the stay in the recovery room assessed up to 2 hours

cumulative opioid consumption within PACU stay

次要结局

  • Postoperative Pain Score-VAS-PACU(during the stay in the recovery room assessed up to 2 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marita Windpassinger M.D.

Principal Investigator

Medical University of Vienna

研究点 (1)

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