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临床试验/NCT06316440
NCT06316440
已完成
不适用

Effect of Noise Isolation During General Anesthesia on the Incidence of Moderate to Severe Postoperative Pain in Patients Undergoing Major Abdominal Surgery

The Second Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 304 人2024年3月12日

概览

阶段
不适用
干预措施
Wear noise-cancelling earphones
疾病 / 适应症
Postoperative Pain
发起方
The Second Affiliated Hospital of Chongqing Medical University
入组人数
304
试验地点
1
主要终点
The incidence of moderate to severe postoperative pain
状态
已完成
最后更新
上个月

概览

简要总结

To investigate the effect of noise isolation during general anesthesia on the incidence of moderate to severe postoperative pain in patients undergoing major abdominal surgery. The aim of this study was to determine whether noise isolation can reduce the Incidence of moderate to severe postoperative pain and analgesic use.

注册库
clinicaltrials.gov
开始日期
2024年3月12日
结束日期
2025年6月30日
最后更新
上个月
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

入排标准

入选标准

  • Between the ages of 18 and 70, both male and female.
  • American Society of Anesthesiologists Classification 1-3
  • Patients undergoing elective major abdominal surgery under general anesthesia(Surgery time ≥ 2h)
  • Voluntarily accept patient controlled intravenous analgesia and signed informed consent

排除标准

  • Patients with previous severe disease
  • Patients with hearing abnormalities
  • Patients requiring mechanical ventilation or undergoing epidural catheters or other types of regional anesthesia after surgery
  • Patients with chronic preoperative pain and/or long-term analgesic use
  • Patients who could not cooperate with the study for any reason

研究组 & 干预措施

Noise-canceling Group

Intraoperative intervention with noise-canceling earphones was performed to isolate the noise

干预措施: Wear noise-cancelling earphones

Control Group

After general anesthesia, the intervention of wearing noise-canceling earphones was not given

结局指标

主要结局

The incidence of moderate to severe postoperative pain

时间窗: From ending of the surgery to 24 hours postoperatively

Moderate to severe postoperative pain:NRS score ≥ 4 (Pain was assessed using NRS scale of 0-10, with 0 being no pain and 10 being most painful)

次要结局

  • Maximum pain score (NRS score) at 0-48 hours postoperatively(From ending of the surgery to 48 hours postoperatively)
  • Patient controlled analgesia pump analgesic consumption(From the time when the surgery was completed until to 48 hours after surgery)
  • Accumulative postoperative pain NRS(From ending of the surgery to 48 hours postoperatively)
  • The incidence of additional analgesic requirements(From the time when the surgery was completed until to 48 hours after surgery)
  • The incidence of moderate to severe postoperative pain(From ending of the surgery to 48 hours postoperatively)
  • Patient controlled analgesia pump analgesic consumption(From the time when the surgery was completed until to 24 hours after surgery)

研究点 (1)

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