| CTRI Number |
CTRI/2025/09/095474 [Registered on: 30/09/2025] Trial Registered Prospectively |
| Last Modified On: |
29/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare ultrasound- guided fluid therapy with standard care for preventing low blood pressure after anaesthesia in patient undergoing brain surgery. |
|
Scientific Title of Study
|
Comparison of Post induction hypotension using point of care Ultrasound-guided fluid therapy versus standard care in Neuro Surgery patient.:A randomized controlled study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sahiba Sumbul |
| Designation |
Junior Resident |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi institute of medical sciences, Patna
Department of Anaesthesiology
13ward block
1st floor
Patna
BIHAR
800014
India |
| Phone |
8603040426 |
| Fax |
|
| Email |
sahiba.sumbul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sahiba Sumbul |
| Designation |
Junior Resident |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi institute of medical sciences, Patna
Department of Anaesthesiology
13ward block
1st floor
BIHAR
800014
India |
| Phone |
8603040426 |
| Fax |
|
| Email |
sahiba.sumbul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahiba Sumbul |
| Designation |
Junior Resident |
| Affiliation |
IGIMS, Patna |
| Address |
Indira Gandhi institute of medical sciences, Patna
Department of Anaesthesiology
13ward block
1st floor
BIHAR
800014
India |
| Phone |
8603040426 |
| Fax |
|
| Email |
sahiba.sumbul@gmail.com |
|
|
Source of Monetary or Material Support
|
| IGIMS PATNA, Department of Anaesthesia, 1st floor 13 ward block
800014 |
|
|
Primary Sponsor
|
| Name |
Sahiba Sumbul |
| Address |
Indira Gandhi institute of medical sciences, Patna
Department of Anaesthesiology
800014 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Dr Swati |
Indira Gandhi Institute of Medical Sciences, Patna |
IGIMS, Patna
Department of Anaesthesiology
13ward block, 1st floor
800014
Patna
BIHAR |
9113463130
swatipgi2006@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Indira Gandhi Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D332||Benign neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Calculated NS bolus |
Calculated NS(fluid) bolus using point of care ultrasound after seeing IVC collapsibility index in preoperative patient 15 minutes before surgery. |
| Comparator Agent |
Routine fluid therapy |
Routine fluid given without seeing IVC. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Elective surgery for space occupying lesion in neurosurgery patient.
ASA 1, 2, 3. |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate.
Uncontrolled hypertension and hypotension.
High risk valvular diseases.
Renal diseases.
Pregnancy.
Emergency Surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean arterial pressure ten minutes after induction of anaesthesia in both the groups( point of care ultrasound group vs conventional fluid therapy group). |
15 min, 30 min, 90min, 120 min,150 min. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of serum lactate at the first post-operative hour(ABG).
Comparison of hemodynamics at 15 min, 30 min, 90min, 120 min,150 min in intraoperative period.
Any reported complications like decreased urine output, less than 0.5 ml/kg BW and appearance of any sign of fluid overload.
Comparison of Total intraoperative fluid required.
Comparison of duration of total hospital stay in both the group.
|
15 min, 30 min, 90min, 120 min,150 min. |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
15/10/2025 |
| 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 Applicable |
| 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
|
This randomized controlled trial will evaluate the effectiveness of point-of-care ultrasound (POCUS)-guided fluid therapy in preventing post-induction hypotension in neurosurgical patients with intracranial space-occupying lesions. Ninety-six ASA I–III patients (15–65 years) undergoing elective surgery will be randomized into POCUS-guided or conventional fluid therapy groups. The primary outcome is mean arterial pressure 10 minutes after induction; secondary outcomes include lactate levels, intraoperative hemodynamics, total fluid requirement, complications, and hospital stay. |