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临床试验/NCT07688811
NCT07688811已完成不适用

Analysis of Risk Factors for Postoperative Nausea and Vomiting (PONV) in Adult Patients at the Post-Anaesthesia Care Unit (PACU) of RSUPN Dr. Cipto Mangunkusumo

Indonesia University1 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2026年1月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
280
试验地点
1
主要终点
Incidence of postoperative nausea and/or vomiting (PONV) during PACU stay

研究概览

简要总结

The goal of this observational study is to determine the incidence of postoperative nausea and vomiting (PONV) and identify its risk factors in adult patients recovering in the post-anaesthesia care unit (PACU) after elective surgery at RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. The main questions it aims to answer are:

  • What is the incidence of PONV among adult patients during their PACU stay?
  • Which patient-, anaesthesia-, and surgery-related factors are independently associated with the occurrence of PONV?

Participants who undergo elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) will be observed for nausea and vomiting from PACU admission until discharge. Researchers will also record the following variables for each participant:

  • Patient factors: age, sex, smoking history, and history of motion sickness or prior PONV
  • Anaesthesia factors: type of anaesthesia, intraoperative opioid use, and PONV prophylaxis use
  • Surgical factors: type of surgery and surgical duration

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

  • Adult patients aged 18 years or older
  • Scheduled to undergo elective surgery under any type of anaesthesia (general anaesthesia, spinal, epidural, or sedation)
  • ASA (American Society of Anesthesiologists) physical status classification I-IV
  • Fully conscious with a Glasgow Coma Scale (GCS) score of 15

排除标准

  • Presence of nausea or vomiting before anaesthesia induction
  • Use of Monitored Anaesthesia Care (MAC) technique
  • Preoperative use of opioids or other emetogenic medications
  • Patient or legal guardian refuses informed consent

研究组 & 干预措施

Adult Elective Surgical Patients

Adult patients aged 18 years or older undergoing elective surgery under any anaesthetic technique (general anaesthesia, spinal, epidural, or sedation) at the Central Surgical Installation of RSUPN Dr. Cipto Mangunkusumo, Jakarta, Indonesia. Participants are observed from PACU admission until discharge for the occurrence of postoperative nausea and vomiting (PONV). Risk factor data collected include age, sex, smoking history, history of motion sickness or prior PONV, type of anaesthesia, intraoperative opioid use, PONV prophylaxis use, type of surgery, and surgical duration.

干预措施: Routine perioperative anaesthesia care (Other)

结局指标

主要结局

Incidence of postoperative nausea and/or vomiting (PONV) during PACU stay

时间窗: Immediate postoperative period (Postoperative Day 0; during PACU stay)

PONV is defined as any episode of nausea (sensation of wanting to vomit without expulsive muscle movement) or vomiting (active expulsion of gastrointestinal contents) occurring after surgery with anaesthesia (general, spinal, epidural, or sedation). Assessed by direct clinical observation and patient interview during PACU monitoring.

次要结局

  • Severity of PONV(Immediate postoperative period (Postoperative Day 0; during PACU stay))

研究者

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

Aldy Heriwardito

Consultant Anaesthesiologist, Department of Anaesthesiology and Intensive Therapy, Faculty of Medicine, Universitas Indonesia - Dr. Cipto Mangunkusumo Hospital

Indonesia University

研究点 (1)

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