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CTRI Number  CTRI/2025/05/087574 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparison of outcome after giving crystalloid and colloid in some participant versus only colloid in some undergoing whipples procedure. 
Scientific Title of Study   A comparative study on outcome following transfusion of concomitant crystalloid and colloid versus only crystalloid in Whipples procedure at Medical College, Kolkata. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anjana Ghosh Dastidar Bose 
Designation  Professor 
Affiliation  Medical College Kolkata 
Address  Department of anaesthesia, Medical college and hospital, Kolkata. 88, college street, college square, Kolkata. Westbengal.

Kolkata
WEST BENGAL
700073
India 
Phone  9831291666  
Fax    
Email  anjanag_dastidar@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Anjana Ghosh Dastidar Bose 
Designation  Professor 
Affiliation  Medical College Kolkata 
Address  Department of anaesthesia, Medical college and hospital, Kolkata. 88, college street, college square, Kolkata. Westbengal.

Kolkata
WEST BENGAL
700073
India 
Phone  9831291666  
Fax    
Email  anjanag_dastidar@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Shreya Mazumdar 
Designation  Postgraduate trainee 
Affiliation  Medical College Kolkata 
Address  Department of anaesthesia, Medical college and hospital, Kolkata. 88, college street, college square, Kolkata. Westbengal.

Kolkata
WEST BENGAL
700073
India 
Phone  9434948654  
Fax    
Email  shreyamazumdar1@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Medical College Kolkata 
Address  88, college street, college square, Kolkata. Westbengal.  
Type of Sponsor  Government medical college 
 
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 
Dr Shreya Mazumdar  Medical college and hospital, Kolkata.  SSB OT-2nd floor, SSB building. DHB OT-2nd floor, DHB building. Department of anaesthesia, 88, college street, college square, Kolkata. Westbengal.
Kolkata
WEST BENGAL 
9434948654

shreyamazumdar1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, MEDICAL COLLEGE KOLKATA. 88, college street, college square, Kolkata. Westbengal.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  COLLOID  COLLOID AND CRYSTALLOID AS IV RESUSITATIVE AGENTS IN WHIPPLES PROCEDURE PATIENTS. 
Comparator Agent  CRYSTALLOID  CRYSTALLOID AS IV RESUSITATIVE AGENTS IN WHIPPLES PROCEDURE PATIENTS. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Undergoing Whipples procedure.
2.Age 30 to 60 years.
3.Weight 45 to 65kg.
4.Hb greater than 10 gram percent.
5.ASA I and II. 
 
ExclusionCriteria 
Details  1.Cardiac disease.
2.Renal compromise.
3.ASA III and IV.
4. Refusal.
5. Any history of allergic reaction or anaphylaxis to colloid.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Alternation 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare hemodynamic effects of transfusion of concomitant colloid and crystalloid versus only crystalloid during intraoperative goal directed fluid resuscitation in patients undergoing in Whipples procedure.  30mins, 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the requirement of renal replacement therapy & intraoperative vasoactive drugs.  30mins, 1st hour, 2nd hour, 3rd hour, 4th hour, 5th hour. 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   03/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  03/06/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In the trial study of 1month duration 10 subjects were administered concomitant crystalloid and colloid. Routine procedure of anaesthesia was followed. Premedication followed by induction followed by maintenance and finally extubation once Whipples procedure was over. Anaesthesia was maintained with positive pressure ventilation with 50 percent oxygen in air with Isoflurane 2percent. Perioperative and postoperative analgesia was maintained. Any adverse effect during intraoperative period will be managed at the discretion of attending anaesthesiologists. Maximum allowable bloodloss was calculated and intervention taken. Patients were preloaded with crystalloid 2hours before induction at 100ml per hour. total intravenous crystalloid given was 1litre till the beginning of dissection. Gelofusion i.e. colloid was given at 150 to 200ml per hour from the start of dissection till the end of it. parameters monitored are heart rate, mean arterial pressure and central venous pressure every 15minutes, urine output hourly and arterial blood gas analysis i.e. ABG was done four times. ABG was done1. before initiation of resection, 2. at the beginning of anastomoses, 3. before extubation, 4. one hour postoperative after extubation. Rate of respective fluid administration was adjusted accordingly. Crystallods were again started after dissection and continued till the end of anastomoses.

RESULTS-

On an average Modified fluid gelation required was 300 to 400ml during dissection.

Mean pH of 10 patients during-

1. before dissection - 7.418

2. during anastomoses - 7.397

3. before extubation - 7.378

4. one hour post extubation - 7.404

 

All patient had average heart rate in range of 70 - 100 beats per minute, mean arterial pressure in range of 60 - 100mmHg, central venous pressure in range of 6 - 9 mmHg.

Mean urine output of 10 patients-

1. before dissection - 122ml

2. during dissection - 127ml

3. start of anastomoses - 100ml

3. before extubation - 276ml

4. one hour post extubation - 87ml.

 

 
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