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临床试验/NCT05596695
NCT05596695招募中不适用

The Effect of Minimizing Blood Pressure Variability on Postoperative Nausea and Vomiting in Women Undergoing Non-cardiac Surgery With Minor to Moderate Risk - a Prospective Randomized Clinical Trial

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2022年10月1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
272
试验地点
2
主要终点
PONV

研究概览

简要总结

Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.

详细描述

Background: Intraoperative hypotension is associated with postoperative nausea and vomiting (PONV). Even though the exact mechanism linking PONV and hypotension is still unclear, a reduced intestinal tissue perfusion might trigger nausea and vomiting. Still to date only limited data evaluating intraoperative blood pressure and the incidence of PONV after general anesthesia exits. Furthermore, the effect of intraoperative blood pressure variability on the incidence of PONV has not been investigated yet. Therefore, we will test our primary hypothesis that the incidence of PONV during the early (0-2h) postoperative period will be minimized by targeting intraoperative blood pressure variability to a SPB of 120±5mmHg by using a continuous vasopressor infusion in female patients undergoing elective minor to moderate risk non-cardiac surgery.

Methods: We will include 272 women between 18 and 50 years of age undergoing minor- to moderate-risk noncardiac surgery in this randomized, double-blinded clinical trial. Patients will randomly be assigned to intraoperative management of blood pressure with a SPB of 120±5mmHg (intervention group) or standard of care intraoperative blood pressure management (control group). Our primary outcome will be the incidence of PONV during the early (0-2h) postoperative period between the groups. Nausea will be assessed in 15-min intervals in the PACU for the first two postoperative hours on a 100mm visual analog scale. A PONV episode will be defined as the occurrence of nausea (VAS 50mm or greater) or vomiting.

Statistics: The primary outcome, the incidence of PONV during the early (0-2 hours) postoperative period will be compared between the intervention and control group using a Chi- Square-Test.

Level of originality: Data regarding the effects of intraoperative blood pressure on PONV are very limited and mainly available from retrospective analysis. So far, the effects of blood pressure variability on PONV have not been investigated yet. As PONV is still one of the most common complications after general anaesthesia leading to delayed discharge from PACU, patient discomfort and increased medical costs, it is important to search for additional methods to manage PONV. Our patient population, being at increased risk of PONV, could therefore profit from a more rapid postoperative recovery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women 18-50 years of age at time of surgery
  • ASA physical status I and II
  • Scheduled for elective minor or moderate risk non-cardiac surgery with expected time of surgery ≥1 hour

排除标准

  • Patients undergoing emergency surgery
  • Scheduled for pheochromocytoma surgery
  • Nausea and/or vomiting on the morning before surgery
  • Taking anti-emetic drugs
  • Pregnancy
  • Dysfunction of the vestibular system

结局指标

主要结局

PONV

时间窗: First two postoperative hours

Incidence of postoperative nausea and vomiting within the first two postoperative hours.

次要结局

  • Secondary Outcome 1: Late PONV(First three postoperative days)
  • Secondary Outcome 2: Modified Aldrete Score(First two postoperative hours)
  • Secondary Outcome 3: Ready for Hospital Discharge Scale(First three postoperative days)

研究者

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

Christian Reiterer

Principal Investigator

Medical University of Vienna

研究点 (2)

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