| CTRI Number |
CTRI/2022/11/047749 [Registered on: 28/11/2022] Trial Registered Prospectively |
| Last Modified On: |
26/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of USG guided aorta index in preventing spinal induced hypotension in patients undergoing below umbilical surgeries |
|
Scientific Title of Study
|
"Comparision of ultrasonographic caval aorta index guided fluid optimisation versus conventional fluid optimisation for averting the spinal induced hypotension,in patients undergoing below umbilical surgeries"-A randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archana Endigeri |
| Designation |
Associate Professor |
| Affiliation |
S.Nijalingappa medical college and HSK hospital |
| Address |
Department of Anaesthesiology,S.Nijalingappa medical college and HSK hspital,Navanagar,Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Archana Endigeri |
| Designation |
Associate Professor |
| Affiliation |
S.Nijalingappa medical college and HSK hospital |
| Address |
Department of Anaesthesiology,S.Nijalingappa medical college and HSK hspital,Navanagar,Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
7406568382 |
| Fax |
|
| Email |
archanaendigeri86@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pulluri SaiTeja |
| Designation |
Junior resident |
| Affiliation |
S.Nijalingappa medical college and HSK hospital |
| Address |
Department of Anaesthesiology,S.Nijalingappa medical college and HSK hspital,Navanagar,Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9886503352 |
| Fax |
|
| Email |
pulluriteja@gmail.com |
|
|
Source of Monetary or Material Support
|
| S Nijalingappa medical college and HSK hospital,bagalkot-587102,Karnataka. |
|
|
Primary Sponsor
|
| Name |
S Nijalingappa medical college and HSK hospital |
| Address |
1st floor, Major OT complex, S Nijalingappa medical college and HSK hospital, Bagalkot. |
| 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 |
| DrArchana Endigeri |
S N Medical College and HSK hospital |
1st floor, S N Medical college and HSK hospital, Bagalkot, Karnataka.
Bagalkot
KARNATAKA |
7406568382
archanaendigeri86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTS RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
CONVENTIONAL FLUID OPTIMISATION |
Fluids will be given without prior ultrasonographic guided caval aorta index. The intervention will be done as long as the surgical procedure proceeds,observing for hypotension and any ionotropes used. |
| Intervention |
ultrasonographic caval aorta index guided fluid optimisation |
The caval aorta index will be derived by taking the ratio of the maximum IVC diameter during expiration and the maximal abdominal aortic diameter during systole. A cut off of 1.2 +/- 2 sd will be approved as fluid responsive. The period of intervention will be as long as the surgical procedure happens,observing for the hypotension and any use of ionotropes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American society of anaesthesiologists(ASA)-1 and 2
for infraumbilical surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.Patient refusal to give consent
2.BMI more than 40kg/m2
3.Emergency surgeries
4.Hypersensitivity to local anaesthetics
5.Patients taking ACE inhibitors
6.Absolute and relative contraindications to spinal anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the relative risk reduction in the incidence of hypotension after fluid optimisation between Group A(Caval aorta guided fluid optimisation) and Group B(Conventional fluid optimisation). |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the total volume of fluid required throughout the procedure and total amount of vasopressors required throughout the procedure and observe the complications if any |
24hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/12/2022 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Significant hypotension is the most common side effect of spinal anaesthesia . Preoperative volume status is one of the predictive variables for developing spinal induced hypotension. Caval aorta index is effective to assess fluid responsiveness and the aim of this study is to evaluate the caval aort a index guided volume optimization to prevent post spinal hypotension. Various parameters have been investigated recently to estimate the preoperative intravascular volume status. Assessing intravascular volume status is still a challenging matter. Sonographic determination of caval aorta index was introduced into clinical practice for assessment of intravascular volume in many studies and reported to be reliable, noninvasive, and easy techniques for evaluating volume status. Thus, identifying a good, easy, reliable and noninvasive predictor for early diagnosis and treatment of spinal induced hypotension is important. Ultrasound technology has gained its popularity and dramatic growth of use inside the operating rooms as a non invasive , low cost and rapid manoeuvre. Caval aorta index is a more effective , quick and convenient method for the evaluation of intravascular volume . In the study we will be comparing two groups with group A as comparision group and groupB as control group. A total of 80 American society of anaethesiologists (ASA) physical status 1 or 2 of age group 18 to 60 years will be considered. Reduction in the incidence of hypotension between the groups, total volume of IV fluids required throughout the procedure, number of boluses of vasopressors required, and complications will be assessed. |