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临床试验/NCT07563530
NCT07563530招募中不适用

Effectiveness of Early Oral Hydration in Relieving Postoperative Thirst in Patients Undergoing Urological Endoscopic Procedures: A Randomized Controlled Trial

Sindh Institute of Urology and Transplantation1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2026年4月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Thirst intensity upon PACU arrival

研究概览

简要总结

This study aims to evaluate whether allowing early oral hydration on demand effectively relieves postoperative thirst and enhances patient satisfaction in individuals undergoing urological endoscopic procedures

详细描述

Postoperative thirst is a frequent but often overlooked discomfort experienced by patients after surgery, particularly following urological endoscopic procedures.Despite the common restriction on carly oral intake due to concerns about nausea and aspiration, delaying hydration prolongs patient suffering and reduces satisfaction during recovery. This study aims to investigate whether allowing carly, on-demand oral hydration in the postanesthesia care unit (PACU) can effectively relieve postoperative thirst without increasing adverse effects, thereby potentially improving patient comfort and outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

The outcome assessor will collect the data from the patients enrolled in this study by the primary investigator in the postanesthesia care unit once the patients are received in the postoperative ward. This data will contain demographics as well as questionnaire-based satisfaction grading and the possible adverse effects.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients aged 18-65 years.
  • Scheduled for elective urological endoscopic procedures under general anesthesia.
  • Day-care endoscopic procedures.
  • ASA classification I-III.

排除标准

  • Known gastrointestinal disorders contraindicating early oral hydration (e.g., peptic ulcer disease, hiatal hernia, irritable bowel syndrome, esophagitis, or prior gastrointestinal surgery).
  • Inability to express thirst or communicate (e.g., language barrier, altered consciousness).
  • Requirement for nasogastric suction.
  • History of facial, oropharyngeal, or laryngeal surgery.
  • Swallowing dysfunction or delayed gastric emptying (e.g., gastroparesis).
  • Incomplete reversal of muscle relaxant at PACU admission (no adequate spontaneous breathing or protective airway reflexes).

研究组 & 干预措施

EOH Group (Early Oral Hydration)

Experimental

Patients in the intervention group will be allowed early oral hydration on demand upon admission to the PACU if they meet the following safety criteria.

Practical PACU checklist to be fulfilled before giving plain water.

Require all of the following before any oral intake (start with small sips, e.g., 10 ml):

干预措施: Early oral hydration (Dietary Supplement)

Control Group (Standard PACU Protocol)

Active Comparator

Patients in the control group will follow the standard PACU protocol, which will delay oral hydration for 2-3 hours after the end of anesthesia. During this period, patients will be monitored closely for thirst and other postoperative symptoms.

干预措施: No early oral hydration (As per Standard PACU Protocol) (Other)

结局指标

主要结局

Thirst intensity upon PACU arrival

时间窗: Up to 2 hours during immediate post-operative period

Patients will be asked Did you experience thirst upon arrival in the PACU? * Yes * No If yes, rate your thirst intensity upon PACU arrival using the Visual Analogue Scale (VAS) on PACU entry. 0 = No thirst, 10 = Worst imaginable thirst \[0---1---2---3---4---5---6---7---8---9---10\]

Thirst intensity at PACU discharge

时间窗: Up to 2 hours during immediate post-operative period

Patients will be asked Did you experience thirst at PACU discharge? * Yes * No If yes, rate your thirst intensity at PACU discharge using the VAS (0-10). 0 = No thirst, 10 = Worst imaginable thirst \[0---1---2---3---4---5---6---7---8---9---10\]

Patient comfort

时间窗: Up to 2 hours during immediate post-operative period

Rate your comfort level during the PACU stay using the VAS (0-10) (0 = Uncomfortable, 10 = Very comfortable) \[0---1---2---3---4---5---6---7---8---9---10\]

Patient satisfaction with the hydration timing.

时间窗: Up to 2 hours during immediate post-operative period

How satisfied are you with the hydration timing? (5-point Likert Scale): * Very Dissatisfied * Dissatisfied * Neutral * Satisfied * Very Satisfied

Patient satisfaction with the hydration procedure.

时间窗: Up to 2 hours during immediate post-operative period

How satisfied are you with the hydration process overall? (5-point Likert Scale): * Very Dissatisfied * Dissatisfied * Neutral * Satisfied * Very Satisfied

Total oral water intake (mL) during PACU stay.

时间窗: Up to 2 hours iduring immediate post-operative period

The total amount of water intake will be restricted to 0.5 mL/kg. The water will be provided in a graduated cup, and the total water intake will be calculated as follows: Total Water Intake (mL) = Volume of water in the cup upon PACU admission - Volume of water remaining in the cup upon PACU discharge.

次要结局

  • Adverse Events(Up to 2 hours during immediate post-operative period)
  • Medical intervention given for any adverse event(Up to 2 hours during immediate post-operative period)

研究者

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

Syed Muhammad Abbas

Professor

Sindh Institute of Urology and Transplantation

研究点 (1)

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