| CTRI Number |
CTRI/2023/08/055959 [Registered on: 01/08/2023] Trial Registered Prospectively |
| Last Modified On: |
28/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know about fluid which is better for patients undergoing neurosurgery |
|
Scientific Title of Study
|
Comparison of effect of balanced salt solution with normal saline on acid base equilibrium in patients undergoing elective neurosurgery |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Agrawal |
| Designation |
Post graduate resident |
| Affiliation |
Vardhaman mahavir medical College and safdarjung hospital |
| Address |
Vardhaman mahavir medical College and safdarjung hospital Ansari nagar new delhi department of anaesthesia ground floor ot building
New Delhi
DELHI
110030
India |
| Phone |
9031201885 |
| Fax |
|
| Email |
ankita.agrawal1801@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meenakshi Kumar |
| Designation |
Professor and consultant |
| Affiliation |
Vardhaman mahavir medical College and safdarjung hospital |
| Address |
Vardhaman mahavir medical College and safdarjung hospital Ansari nagar new delhi department of anaesthesia and intensive care unit ground floor ot building
New Delhi
DELHI
110030
India |
| Phone |
9899689829 |
| Fax |
|
| Email |
drmeenakshi86@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Agrawal |
| Designation |
Post graduate resident |
| Affiliation |
Vardhaman mahavir medical College and safdarjung hospital |
| Address |
Vardhaman mahavir medical College and safdarjung hospital Ansari nagar new delhi department of anaesthesia and intensive care unit ground floor ot building
DELHI
110030
India |
| Phone |
9031201885 |
| Fax |
|
| Email |
ankita.agrawal1801@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaman mahavir medical College and safdarjung hospital |
|
|
Primary Sponsor
|
| Name |
Vardhaman mahavir medical College and safdarjung hospital |
| Address |
Vardhaman mahavir medical College and safdarjung hospital Ansari nagar new delhi |
| 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 |
| Ankita Agrawal |
Vardhaman mahavir medical College and safdarjung hospital |
Department of anaesthesia ground floor ot building
New Delhi
DELHI |
9031201885
ankita.agrawal1801@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee VMMC and safdarjung |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balanced salt solution |
Given during surgery according to gole directed fluid to be given during the whole surgical procedure |
| Comparator Agent |
Balanced salt solution sterofundin with normal saline |
Sterofundin is a balance salt solution which contain less sodium in comparison to normal saline and has other important electrolytes which is helpful in better outcome |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists physical status 1-2 schedule for elective surgery |
|
| ExclusionCriteria |
| Details |
1.Repeat craniotomies
2.Patients with history of diabetes insipidus or syndrome of inappropriate antidiuretic harmones
3.patients on diuretic mannitol or hypertonic saline before surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of balanced salt solution with normal saline on acid base equilibrium |
1 yr 18 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of balanced salt solution with normal saline on serum electrolytes & serum osmolarity |
1year 18 month |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2023 |
| 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 study is randomised comparative study to compare effect of balanced Salt solution with normal saline on acid base equilibrium in patients undergoing elective neurosurgery by doing ABG at start of surgery then hourly and end of surgery. |