| CTRI Number |
CTRI/2024/07/071737 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study |
| Study Design |
Other |
|
Public Title of Study
|
Role of ultrasonographic Inferior Vena Cava collapsibility index in predicting spinal anaesthesia induced hypotension in elective lower abdominal surgeries. |
|
Scientific Title of Study
|
Role of ultrasonographic Inferior Vena Cava collapsibility index in predicting spinal anaesthesia induced hypotension in elective lower abdominal 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 Disha Shah |
| Designation |
Senior Resident doctor |
| Affiliation |
|
| Address |
Room no 105, ground floor, Anaesthesiology department, GCS Medical College Hospital and Research centre, Opp DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
|
| Fax |
|
| Email |
dr.disha1994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Desai |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Room no 105, ground floor, Anaesthesiology Department, GCS Medical College Hospital and Research centre, Opp DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429525791 |
| Fax |
|
| Email |
shru30791@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Desai |
| Designation |
Assistant professor |
| Affiliation |
|
| Address |
Room no 105, ground floor, Anaesthesiology Department, GCS Medical College Hospital and Research centre, Opp DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9429525791 |
| Fax |
|
| Email |
shru30791@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College Hospital and Research centre,Anaesthesiology Department, ground floor, room no 105, Opp DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad - 380025, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital and Research centre |
| Address |
GCS Medical College Hospital and Research centre,Anaesthesiology Department, ground floor, room no 105, Opp DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad - 380025, Gujarat, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shruti Desai |
GCS Medical College Hospital and Research centre |
Room no 105, ground floor, Anaesthesiology Department, Opp. DRM Office, Near Chamunda Bridge, Naroda road, Ahmedabad- 380025
Ahmadabad
GUJARAT |
9429525791
shru30791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee (IEC GCSMCH & RC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Not applicable |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who have given written informed consent posted for elective lower abdominal surgeries under spinal anaesthesia requiring spinal level T6-T8 under supine position, ASA grade I and II and BMI less than 30 kg/m2 will be included in our study
|
|
| ExclusionCriteria |
| Details |
ASA III and IV
Pregnant patients
Patients with baseline BP less than 90mmHg
Raised intra-abdominal pressure
BMI more than 30kg/m2
Patients undergoing unilateral spinal anaesthesia
Patients with known allergy to local anaesthetics
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ultrasonographic inferior vena cava collapsibility index more 35 will predict spinal anaesthesia induced hypotension |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Non-invasive predictor for spinal anaesthesia induced hypotension |
8 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| 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="0"
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
|
Written informed consent will be taken. Patients will be kept nil by mouth as per standard protocol. In the operating theatre, 18G cannula will be secured in a peripheral vein, standard monitoring will be applied and baseline HR, SBP, DBP, MAP & SpO2 will be recorded before administering SA in supine position. Ultrasound guided IVC diameter measurements will be done by an experienced anaesthetist using a curvilinear probe of 1-8 MHz during spontaneous breathing through subxiphoid view lateral to the IVC-hepatic vein junction. IVC anterioposterior diameter which is maximum during expiration (IVCmax) and minimum during inspiration (IVCmin) will be taken in one respiratory cycle using M-mode of ultrasound. IVCCI will be calculated using the formula: [{IVCmax-IVCmin}/IVCmax]*100. No fluid preloading will be done and the infusion of Ringer’s Lactate solution at a rate of 10ml/kg/hr will be started only after administration of SA in a sitting position at L3-L4 intervertebral space with a dose of 3.5 ml of 0.5% hyperbaric bupivacaine through 25G spinal needle to achieve spinal blockade of T8. Patients will be kept supine after SA and the pin prick test will be used to evaluate the level of sensory blockade. HR, SBP, DBP, MAP and SpO2 will be recorded every 2 minutes for 10 minutes and every 5 minutes for 30 minutes after the administration of SA. SAIH (spinal anaesthesia induced hypotension) will be defined as a decrease in SBP by more than 20% of the baseline value or MAP <60 mmHg. Any episode of hypotension will be noted and managed with 6mg i.v. mephentermine to keep BP within 20% of baseline. Any complications like bradycardia, nausea or vomiting will be noted and managed accordingly All the factors known to affect SAIH i.e. age, gender, height, weight, BMI, IVCCI will be included in the final multivariate model for finding the single most useful SAIH predicting variable..
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