跳至主要内容
临床试验/CTRI/2022/01/039159
CTRI/2022/01/039159尚未招募不适用

Comparative study of ringer lactate and balanced salt solution on acid base and electrolyte status in emergency laparotomy

Institute of medical science Banaras Hindu university1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Changes in Acid-base and electrolyte status (ABG analysis)

研究概览

简要总结

Our study include total 60 patients of intestinal obstruction and perforation undergoing emergency exploratory laparotomy. After Ethical approval, Written informed consent from each patient or his relative will be taken before the procedure.

Inclusion Criteria:

1.     Age group between 18 and 60 years.

2.  Patient received from emergency of SSH within 24hr of admission after resuscitation.

Exclusion criteria

  1.  Patient/relative refusal.

  2. Patient on high inotropic support.

3.  Patient with any systemic illness like Diabetes, Hypertension etc.

4.  Patient with end stage organ damage e.g. hepatic, renal or cardiovascular disorder.

5.  Patients with abdominal trauma.

The patients will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelope technique into two equal groups (each 30 patients).

Group R: Will receive Ringer Lactate as intraoperative maintenance fluid.

Group B: Will receive Balanced Salt Solution as intraoperative maintenance fluid up to 6 hours postoperatively.

Patient received in emergency department will be managed and resuscitated as per protocol for management of intestinal obstruction/perforation. Baseline investigations including arterial blood gas (ABG) analysis will be sent. Written informed consent will be taken from all patients before surgical intervention. Those patients will be enrolled in our study who meet the inclusion criteria. Demographic profile and baseline parameters will be recorded. Laparotomy will be done under general anaesthesia with epidural catheter in place for post op analgesia. ABG will be repeated immediately after extubation and 6 hour’s postoperatively. pH, base excess, serum bicarbonate, sodium, potassium, chloride, lactate and serum osmolality will be recorded and compared between two groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patient received from emergency of SSH within 24 hrs of admission after resuscitation.

排除标准

  • 1-Patients/relative refusal.
  • 2-patient on high inotropic support.
  • 3-patient with any systemic illness like diabetes, hypertension etc.
  • 4-patient with end stage organ damage eg.hepatic renal or cardiovascular disorder.
  • 5-patient with abdominal trauma.

结局指标

主要结局

Changes in Acid-base and electrolyte status (ABG analysis)

时间窗: -Preoperative, | -After extubation | -6 hours after extuabtion

次要结局

  • Associated side effects(6hr postop)

研究者

发起方
Institute of medical science Banaras Hindu university
申办方类型
Research institution and hospital

研究点 (1)

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