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临床试验/NCT07488078
NCT07488078招募中1 期

Effect of Liberal Versus Restrictive Intravenous Fluid Administration on Postoperative Homeostasis in Patients Undergoing Laparoscopic Cholecystectomy

King Edward Medical University1 个研究点 分布在 1 个国家目标入组 380 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
380
试验地点
1
主要终点
Mean Systolic Blood Pressure

研究概览

简要总结

The goal of this clinical trial is to learn whether giving less intravenous (IV) fluid (restrictive administration) after surgery is as effective as giving more IV fluid (liberal administration) in maintaining body stability (homeostasis) among adults undergoing laparoscopic gallbladder removal (cholecystectomy).

The main questions it aims to answer are:

Does restrictive IV fluid administration maintain stable blood pressure, heart rate, and urine output after laparoscopic cholecystectomy?

Are there any differences in postoperative recovery or complications between restrictive and liberal fluid regimens?

Researchers will compare patients receiving liberal IV fluid administration with those receiving restrictive IV fluid administration to see if both methods maintain similar postoperative homeostasis and recovery outcomes.

Participants will:

Be adults aged 18-60 years (ASA class I-II) undergoing elective laparoscopic cholecystectomy.

Be randomly assigned to one of two groups:

Group A: Liberal IV fluid administration for 6 hours after surgery.

Group B: Restrictive IV fluid administration for 6 hours after surgery.

Have their vital signs (pulse, blood pressure, mean arterial pressure) and urine output recorded at multiple time points after surgery (immediate, 3, 6, 12, and 24 hours).

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All patients undergoing elective cholecystectomy
  • Age : 18-60 years
  • All genders
  • ASA class 1 and 2

排除标准

  • History of previous laparotomy
  • Perforated gall bladder
  • Duration of surgery more than 3 hours
  • More than 100ml intra operative blood loss

结局指标

主要结局

Mean Systolic Blood Pressure

时间窗: Day 1

Mean systolic blood pressure at preoperative and 3,6, 12 and 24 hours post operatively

次要结局

  • Mean Pulse Rate Per Minute(Day 1)
  • Mean Diastolic Blood Pressure(Day 1)
  • Mean Pulse Pressure(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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