| CTRI Number |
CTRI/2025/12/099789 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
23/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Fluid therapy ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two fluid therapies Plethysmography Variabilty Index based Goal Directed Fluid Therapy versus Conventional Liberal Fluid administration in adult patients undergoing elective gynaecological surgeries. |
|
Scientific Title of Study
|
A study to compare Plethysmography Variabilty Index based Goal Directed Fluid Therapy versus Conventional Liberal Fluid administration in adult patients undergoing elective gynaecological surgeries. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karitika Kashyap |
| Designation |
Junior Resident |
| Affiliation |
Guru Gobind Singh Medical college Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9736898258 |
| Fax |
|
| Email |
Kashyapkaritika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical college Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarvjeet Kaur |
| Designation |
Professor and Head |
| Affiliation |
Guru Gobind Singh Medical college Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab India
Faridkot
PUNJAB
151203
India |
| Phone |
9915680508 |
| Fax |
|
| Email |
drsarvjeetk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab 151203 India |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College Hospital |
| Address |
Department of Anaesthesiology Guru Gobind Singh Medical College Hospital Faridkot Punjab 151203 India |
| 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 Karitika Kashyap |
Guru Gobind singh medical college Faridkot |
Department of anaesthesiology Guru Gobind Singh medical college
Faridkot
PUNJAB |
9736898258
Kashyapkaritika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Guru Gobind Singh medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional liberal fluid therapy. |
Patients will recieve preload of 500 ml of crstalloid and then a continous infusion of 4-8 ml/kg /hr of 0.9% normal saline using holiday segar method. Blood loss will be replaced by 3:1 crystalloid ratio and colloid as 1:1 ratio. Parameters such as total fluid given total urine output , heart rate blood pressure,pre and post op abg ,cbc and serum creatinine will be mesured. |
| Intervention |
Plethysomography variability index (PVI)based goal directed fluid therapy. |
Patients will receive a preload of 500 ml crystalloid and then maintenance fluid will be started at 2ml/kg /hr. The plethysmography variability index will be measured and if it comes less than 14 percentage will continue the same rate of maintenance fluid. If the percentage is more than 14 we will proceed with fluid challenge. 250 ml of colloid or 250 to 500 ml of crystalloid over 10 min.Parameters such as total fluid given total urine output , heart rate blood pressure,pre and post op abg ,cbc and serum creatinine will be mesured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
American society of anaesthesiology physical status 1 & 2.
Patients aged from 18 to 65 years.
Patients undergoing elective gynaecological surgeries under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Arrhythmias or significant cardiac disease
Severe pulmonary disease.
Peripheral vascular diseases affecting plethysmographic readings
Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of plethysmography variability index based goal directed fluid therapy on mean arterial pressure. |
During elective gynaecological surgeries |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of conventional fluid management on mean arterial pressure. |
During elective gynaecological surgeries. |
| To compare the effect of plethysmography variability index based goal directed fluid therapy versus conventional fluid management on mean arterial pressure. |
During elective gynaecological surgeries . |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
13/01/2026 |
| 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="6"
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
|
Goal Directed fluid therapy aims to tailor fluid administration to the individual patient’s real time physiological needs, using various objective haemodynamic parameters among which plethysmography variability index has emerged as a promising, non invasive and continous monitoring tool derived from the pulse oximetry waveform. The aims is to compare effect of Plethysmography Variability Index based goal directed fluid therapy vs conventional liberal fluid therapy in terms of mean arterial pressure during gynaecological surgery. |