| CTRI Number |
CTRI/2024/07/071658 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
31/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Administering fluids in advance to prevent low blood pressure in patients undergoing surgery with spinal anesthesia. |
|
Scientific Title of Study
|
Effect of inferior vena cava collapsibility index guided fluid optimization on incidence of hypotension after subarachnoid block in patient undergoing infraumbilical 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 |
Dr Sumit Kumar |
| Designation |
Post graduate resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Dagar, New Delhi
New Delhi
Delhi
110029
India
New Delhi
DELHI
110029
India |
| Phone |
7683078340 |
| Fax |
|
| Email |
sumitchoudhary4383@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Dagar, New Delhi
New Delhi
Delhi
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Gupta |
| Designation |
Professor and Consultant |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care, Vardhman Mahavir Medical College and Safdarjung hospital, Ansari Dagar, New Delhi
New Delhi
Delhi
110029
India
New Delhi
DELHI
110029
India |
| Phone |
9910382190 |
| Fax |
|
| Email |
amitaguptadr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sumit Kumar |
Vardhman Mahavir Medical College and Safdurjung Hospital |
Department of anaesthesia, Main OT building, Room no 3, division 1, Ground floor ,vardhman Mahavir Medical College and Safdurjung Hospital, Ansari Nagar, New Delhi
New Delhi
DELHI |
7683078340
sumitchoudhary4383@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of VMMC and Safdarjung hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40-K46||Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
IV fluid boluses of normal saline |
Fluid boluses of normal saline will be given at 5ml/kg over 15 minutes. |
| Comparator Agent |
No fluid boluses |
Fluid boluses of normal saline at 5ml/kg over 15 minutes will not be given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 or 2 undergoing elective infraumblical and lower limb surgery |
|
| ExclusionCriteria |
| Details |
1.Contraindications for subarachnoid block
2.Pregnancy
3.Body Mass Index more than 30 kg per meter square |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of hypotension after subarachnoid block using inferior vena cava collapsibility index guided volume optimization in patients undergoing infraumbilical surgeries |
Every 5 minutes till 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of fluid boluses required in preoperative room.
2.The total amount of IV fluid required in both the groups.
3.Total dose of mephentermine used in both the groups.
4.Total number of patients who had episode of bradycardia in both the groups. |
Every 5 minutes till 30 minutes |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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
|
This study is prospective comparative study to assess the incidence of hypotension after subarachnoid block using inferior vena cava collapsibility index guided volume optimization in patients undergoing infraumbilical surgeries. Inferior vena cava collapsibility index will be measured using USG. If Inferior vena cava collapsibility index will be more than 3 percent, then patient will receive Fluid boluses and repeat IVC USG will be done and fluid boluses will be given accordingly till IVC CI become less than 35 percent. Sensory block and motor block will be assessed every 5 min with strict vital monitoring will be done. The variables observed are total amount of fluid given in both the group, number of patients who developed hypotension in both the groups and the number of patients developing bradycardia.
|