Safety and Feasibility of Early Oral Hydration After Video-assisted Thoracoscopic Surgery: A Prospective, Randomized, and Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Mouth dryness
研究概览
简要总结
The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:
- the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.
- the degree of improvement in sore throat and dry mouth after oral hydration.
- the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.
- the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.
- patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.
Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room.
详细描述
Anesthesiologists assess the removal of the endotracheal tube post-surgery and the patient is then transferred to the recovery room for rest. The principal investigator will evaluate the consciousness status and risk of nausea and vomiting to confirm eligibility for the trial. Subsequently, the following grouping will be conducted:
- Experimental group
- First, moisten the patient's throat with a cotton swab dipped in water. If no nausea or vomiting occurs after five minutes, proceed to the next stage.
- Provide an ice cube for the patient to hold in their mouth. If no nausea or vomiting occurs after ten minutes, proceed to the next stage.
- Offer 10-20ml water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml of water every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.
- Comparison group - standard care without any intervention
Evaluate the level of throat pain using VAS (Visual Analogue Scale) score, the incidence, timing, frequency of post-operative nausea and vomiting, the level of mouth dryness, the satisfaction of patients in recovery room, and the vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged 18 to
- •Anesthesia physical status classification III or below
- •Body Mass Index 30 or below
- •Elective video-assisted thoracoscopic surgery
排除标准
- •Pre-operative throat pain
- •Impaired mental status
- •Tendency to choke (inc. dysphagia, stroke hx.)
- •Nil Per Os (NPO) less than 8 hours
- •Pregnancy
- •Nausea and vomiting in Operating room or Post-anesthesia care unit
研究组 & 干预措施
Oral hydration
wet swab-ice cube-small amount of water
干预措施: Oral hydration (Behavioral)
No hydration
According to routine care, no oral fluid supplementation is provided.
结局指标
主要结局
Mouth dryness
时间窗: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
Modified Schirmer tear strip test
sore throat level by VAS (Visual Analogue Scale)
时间窗: From patient arrived at the PACU (Postanesthesia Care Unit) to patient being discharged, about 1-3 hours
sore throat level by VAS (Visual Analogue Scale) measured by 0-10 point-scale
次要结局
- post-operative nausea and vomiting (PONV)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours)
- Blood pressure in PACU (Postanesthesia Care Unit)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours)
- Heart Rate in PACU (Postanesthesia Care Unit)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge in every 5 minutes, about 1-3 hours)
- Patient's satisfaction(Through study completion, before patients leaving PACU (Postanesthesia Care Unit))
- timing of post-operative nausea and vomiting (PONV)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours)
- duration of post-operative nausea and vomiting (PONV)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours)
- management of post-operative nausea and vomiting (PONV)(From patient been sent to PACU (Postanesthesia Care Unit) until discharge, about 1-3 hours)