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CTRI Number  CTRI/2020/03/024318 [Registered on: 27/03/2020] Trial Registered Prospectively
Last Modified On: 26/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The study to show factors affecting early recovery after surgery including fluid management 
Scientific Title of Study   “A randomised prospective study to compare the implementation of SGPGI enhanced recovery program(SERP) including goal directed fluid therapy Vs. standard therapy in major abdominal surgeries”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sandeep Sahu 
Designation  Additional Professor 
Affiliation  SGPGI 
Address  Department of Anesthesia SGPGI

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Sahu 
Designation  Additional Professor 
Affiliation  SGPGI 
Address  Department of anesthesia, SGPGI

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pratibha Yadav 
Designation  junior resident 
Affiliation  SGPGI 
Address  Department of anesthesia, SGPGI

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004902312  
Fax    
Email  pratibhayadav280@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  DrSandeep Sahu 
Address  additional professor,sgpgi,lko 
Type of Sponsor  Other [self] 
 
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 
DrSandeep Sahu  Sanjay Gandhi Postgraduate institute  Department of anesthesia,SGPGI,LKO
Lucknow
UTTAR PRADESH 		 8004904598

drsandeepsahu09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,SGPGI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K918||Other intraoperative and postprocedural complications and disorders of digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  CVP Guided STANDARD GROUP  normal CVP 8-12 cm H2O maintained by 1-2ml/kg/hr if CVP less than 8 then 200 ml fliud bolus will be given and again assesed after 20 min 
Intervention  SVV Guided GDT Group  Fluid will be given acc. to SVV using FLOTRAC SYSTEM. normal SVV 10-12 (maintained by 1-2 ml/kg/hr) if more then 12 then 200ml fluid bolus will be given and SVV will be again assesed after 20 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients willing to participate
Pt age: > 18 yrs and found fit for major abdominal surgery
ASA 1 and 2
Patients undergoing major abdominal surgeries including
Whipple’s procedure
Colorectal surgeries

 
 
ExclusionCriteria 
Details  Patient’s refusal to participate
Patients with severe, persistent peripheral vasoconstriction or arterial spasm, such as in shock states
Device related exclusion criteria :
Patients of dilated cardiomyopathy with left ventricular ejection fraction less than 40%
Patients with artificial hearts and ventricular assist devices (VAD).
Patients with severe, persistent arrhythmias
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study and compare the postoperative length of stay in postop ICU in SGPGI Early Recovery Program (SERP) group utilising goal directed fluid therapy (by FloTrac/Vigileo ,SVV guided fluid therapy ) with standard therapy group utilising CVP based intraoperative fluid management.  24 hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To study and compare the intraoperative fluid requirement in the SERP(SVV) and standard therapy group(CVP). (total fluid given, bolus given, ml/kg body wt. fluid in both groups).
To compare the intraoperative hemodynamics in both group.
To compare the pain scores with Visual Analogue Scale (VAS) in both groups.
Incidence of nausea and vomiting in both groups.
To Study the adverse perioperative events and complications.
 		 24 hrs 
 
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   Phase 1 
Date of First Enrollment (India)   01/04/2020 
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="1"
Months="8"
Days="7" 
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)?  

Brief Summary   Fluid balance is a major contributing factor to postoperative morbidity and mortality. Persistant hypovolemia is associated with organ hypoperfusion,systemic inflammatory response syndrome,sepsis and multiple organ failure. Fluid overload, on the other hand, is associated with edema , ileus, postoperative nausea and vomiting, pulmonary complications and increased cardiac demand. Our aim is to demonstrate that a low volume fluid management strategy does not adversely affect outcome and also to apply enhance recovery program to the patients undergoing major abdominal surgeries to improve the overall outcome by decreasing the fasting duration by giving a carbohydrate load 2 hrs prior to surgery, adequate analgesia preferably non narcotic analgesia, adequate control of PONV and to study and compare the pain scores, hospital stay and any associated complications. Enhanced recovery programs were initially formulated for various GI surgeries and later applied to various other surgeries. After taking written and informed consent from the patient, this study would be conducted in adult patients ( >18 and found fit for surgery), irrespective of gender, undergoing major abdominal surgeries. The intraoperative fluid requirement with a guided fluid therapy and the postoperative pain scores, incidence of nausea-vomiting, incidence of PONV and perioperative complications will be studied in comparison with a standard operative care group. 
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