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临床试验/CTRI/2025/11/097138
CTRI/2025/11/097138尚未招募4 期

Liberal versus Restrictive Fluid Management in Ambulatory Laparoscopic Gynaecological Surgeries: A Randomized Controlled Trial

DR RAM SINGH1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Time to attain hospital discharge criteria

研究概览

简要总结

Optimal perioperative fluid management is an ongoing challenge in anaesthesia practice. While liberal fluid administration has been traditionally recommended to compensate for preoperative fasting and surgical stress, concerns remain regarding potential fluid overload and delayed recovery. Conversely, restrictive regimens, though widely adopted in major abdominal and thoracic surgeries, may risk inadequate tissue perfusion. The applicability of these findings to short-duration, ambulatory laparoscopic gynaecological procedures remains uncertain.

Day-care surgeries demand rapid recovery, minimal postoperative symptoms, and early discharge. Small studies in minor surgery suggest that intravenous fluid therapy can reduce dizziness, thirst, fatigue, and nausea, thereby improving patient comfort and recovery. However, evidence remains inconsistent, and there are no clear guidelines on the optimal intraoperative fluid regimen for this subset of patients.

This randomized controlled trial aims to compare liberal versus restrictive intraoperative fluid administration in ambulatory laparoscopic gynaecological surgery, focusing on time to discharge readiness and patient-centred recovery outcomes. The study is expected to generate robust evidence that will inform perioperative practice and enhance patient safety, satisfaction, and efficiency of ambulatory care.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • 1 ASA I-II 2 Duration of surgery less than 90 minutes 3 Diagnostic laparoscopy and hysteroscopy 4 Minor laparoscopic procedure.

排除标准

  • 1 Patient refusal 2 Hemoglobin level less than 10gm percent 3 Known cardiac or renal disease.

结局指标

主要结局

Time to attain hospital discharge criteria

时间窗: Time in minutes from arrival in PACU to discharge readiness with Modified PADDS score of 9 or more

次要结局

  • Postoperative pain(Pain using Visual Analogue Scale of 100 mm on arrival at PACU and at Discharge)
  • Postoperative Nausea and Vomiting PONV(PONV score using a 0 to 3 PONV score on arrival in PACU and at discharge)
  • Presence or absence of dizziness fatigue and thirst(Recorded as binary response Yes/No on arrival in PACU and at Discharge)
  • Modified PADSS score for discharge readiness(On Arrival in PACU and At Discharge)

研究者

发起方
DR RAM SINGH
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

DR RAM SINGH

All India Institute of Medical Sciences New Delhi

研究点 (1)

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