| CTRI Number |
CTRI/2024/04/066498 [Registered on: 29/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To measure the size of inferior vena cava before surgery and to correct low blood pressure that might be caused due to spinal anesthesia |
|
Scientific Title of Study
|
Evaluation of effectiveness of fluid management using ultrasound guided inferior vena cava collapsibility index in preventing spinal anaesthesia induced hypotension in urology surgeries - An open-label 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 |
Dr Teepak Siddartha R |
| Designation |
Post graduate (MD Anaesthesiology) |
| Affiliation |
SRM Medical College hospital and Research centre |
| Address |
No:209,B-Block,2nd floor,Department of anaesthesiology,
SRM Medical College Hospital And Research Centre,Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7598374060 |
| Fax |
|
| Email |
teesiddrox@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand K |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room no:209,B-Block,2nd floor,Department of anesthesiology,
SRM Medical College Hospital And Research Centre,Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
dranandkuppusamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand K |
| Designation |
Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room no:209,B-Block,2nd floor,Department of anesthesiology,
SRM Medical College Hospital And Research Centre,Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9865282288 |
| Fax |
|
| Email |
dranandkuppusamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Centre,Kattankulathur,Kancheepuram,Tamil Nadu,India,603203 |
|
|
Primary Sponsor
|
| Name |
SRM medical college |
| Address |
Room 209,B-Block,2nd floor,Department of anesthesiology,SRM medical college hospital and research centre,Kattankulathur |
| Type of Sponsor |
Private 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 Teepak siddartha R |
SRM Institute of science and technology |
Room no 208,B-Block,2nd floor,department of anesthesiology,SRM medical college hospital and research centre,Kattankulathur
Kancheepuram
TAMIL NADU |
7598374060
teesiddrox@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Commitee - Students |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional preloading before spinal anesthesia |
To preload 10ml/kg crystalloids before administering spinal anesthesia |
| Intervention |
Inferior vena cava guided preloading before spinal anesthesia |
To administer crystalloids based on the collapsibility of inferior vana cava |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2
Urology surgery |
|
| ExclusionCriteria |
| Details |
Patients with coagulopathies
Patients with neuropathies
Patients with sepsis
Uncompensated systemic disorders
Transurethral resection of prostate
Patients not consenting to spinal anesthesia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the difference in incidence of spinal anaesthesia induced hypotension in group A and group B |
1min,5min,10min,15min,20min,25min,30min,40min,50min,60min,and every 15min till end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the volume of crystalloids transfused intraoperatively to manage spinal induced hypotension |
End of surgery |
| To assess the quantity of vasopressor ephedrine used intraoperatively to manage spinal induced hypotension |
End of surgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
16/05/2024 |
| 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="0"
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
|
A total of 100 patients belonging to age group 18 years to 65 years , ASA 1 and 2 undergoing urology surgeries will be studied,In this open-label randomized controlled trial a total of 100 patients will be divided into two groups Group A (preloading with 10ml/kg crystalloids) and Group B(optimising the fluid status by IVCCI preoperatively).Both the groups will undergo subarachnoid blockade using 2.5ml of Inj.Ropivacaine 0.75% using 25gauge quicke needle at L3-L4 vertebral space.If patients develop hypotension(defined as 20% drop in mean arterial pressure from baseline) 10ml/kg crystalloids will be administered initially followed by vasopressor ephedrine in 6mg bolus dose till mean arterial blood pressure increase to more than 70mmhg.Data collection will be done by measuring the volume of crystalloids, vasopressor ephedrine given and and difference in incidence of hypotension will be assessed. |