| 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
|
|
|
Primary Sponsor
|
| Name |
Medical College Kolkata |
| Address |
88, college street, college square, Kolkata.
Westbengal.
|
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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. |