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CTRI Number  CTRI/2022/01/039159 [Registered on: 05/01/2022] Trial Registered Prospectively
Last Modified On: 04/01/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [fluid administration]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Two different type of fluids in emergency laparotomy patients 
Scientific Title of Study   Comparative study of ringer lactate and balanced salt solution on acid base and electrolyte status in emergency laparotomy  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ramik chaudhary 
Designation  Junior resident 
Affiliation  IMS BHU VARANASI 
Address  department of anesthesiology , IMS,BHU

Varanasi
UTTAR PRADESH
221005
India 
Phone  8447859045  
Fax    
Email  ramikchaudhary01@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yaspal singh  
Designation  Profeesor 
Affiliation  IMS,BHU,VARANASI 
Address  Department of anesthesiology,IMS,BHU,varanasi

Varanasi
UTTAR PRADESH
221005
India 
Phone  9918424416  
Fax    
Email  dryashacin1999@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yaspal singh  
Designation  Profeesor 
Affiliation  IMS,BHU,VARANASI 
Address  Department of anesthesiology,IMS,BHU,varanasi


UTTAR PRADESH
221005
India 
Phone  9918424416  
Fax    
Email  dryashacin1999@gmail.com  
 
Source of Monetary or Material Support  
INSTITUTE OF MEDICAL SCIENCES, BHU 
 
Primary Sponsor  
Name  Institute of medical science Banaras Hindu university 
Address  Department of anesthesiology, institute of medical science, BHU, varanasi UP,INDIA 221005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ramik Chaudhary  Sir Sundarlal Hospital  Department of anesthesiology , IMS,BHU
Varanasi
UTTAR PRADESH 
8447859045

ramikchaudhary01@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K631||Perforation of intestine (nontraumatic),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Balanced salt solution   Group B will receive Balanced Salt Solutions as intraoperative maintenance fluid up to 6 hours postoperatively. 
Intervention  Ringer lactate  Group R will receive Ringer Lactate as intraoperative maintenance fluid up to 6 hours postoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient received from emergency of SSH within 24 hrs of admission after resuscitation. 
 
ExclusionCriteria 
Details  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. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in Acid-base and electrolyte status (ABG analysis)  -Preoperative,
-After extubation
-6 hours after extuabtion 
 
Secondary Outcome  
Outcome  TimePoints 
Associated side effects  6hr postop 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/01/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 criteriaDemographic 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. 

 
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