CTRI/2025/11/097582招募中不适用
Effect of early postoperative oral hydration on thirst, comfort and metabolic stress markers following regional anaesthesia: A randomized controlled trial.
Pt BD Sharma Postgraduate Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年12月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- To compare the change in postoperative thirst intensity between the early hydration and standard delayed hydration groups using visual analog scale (VAS).
研究概览
简要总结
This study is to evaluate whether early oral intake of clear fluids, initiated within two hours of surgery under regional anesthesia, is safe and effective in improving patient comfort and modulating postoperative stress markers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Adult patients aged 18–60 years.
- •2 ASA physical status I–II.
- •3 Undergoing non gastrointestinal surgery under regional anaesthesia.
- •4 Able to provide informed consent and understand instructions.
排除标准
- •1 Patients refusing to participate.
- •2 Patients with diabetes mellitus.
- •3 Known adrenal or endocrine disorders, dyselectrolytemia in last 48 hours.
- •4 Gastrointestinal surgery or contraindication to early oral intake.
- •5 Intraoperative conversion to general anaesthesia.
- •6 Prolonged sedation or delayed recovery.
- •8 Intraoperative use of antiemetics and steroids.
结局指标
主要结局
To compare the change in postoperative thirst intensity between the early hydration and standard delayed hydration groups using visual analog scale (VAS).
时间窗: TB - Baseline (15 minutes after shift to PACU) | T0 - Immediately after first intake of 10 ml water | T1 - 1 hour after first intake | T2 - 2 hours after first intake | T6 – 6 hours after first intake
次要结局
- 1. To compare subjective comfort using visual analog scale (VAS).(TB - Baseline (15 minutes after shift to PACU))
- 2. To compare serum cortisol concentrations at 6 hours post-operatively as an indicator of perioperative stress response.(T6 – 6 hours after first intake)
- 3. To compare blood glucose levels between early and standard delayed hydration groups to assess metabolic response to early hydration.(TB - Baseline (15 minutes after shift to PACU))
- 4. To compare the timing of initiation and tolerance of oral feeding in both the groups.(TB - Baseline (15 minutes after shift to PACU))
- 5. To compare the incidence of post-operative nausea and vomiting.(T1 - 1 hour after first intake)
研究者
Dr. Manisha Manohar
Pt. B.D. Sharma Postgraduate Institute of Medical Sciences
研究点 (1)
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