| CTRI Number |
CTRI/2023/07/055782 [Registered on: 27/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Predicting Post Spinal Anaesthesia induced hypotension in lower limb surgeries with the help of ultrasound and perfusion index measured through pulse oximeter |
|
Scientific Title of Study
|
Comparison of ultrasonographic inferior vena cava collapsibility index, caval aorta index and perfusion index for prediction of post spinal anaesthesia hypotension in lower limb surgeries. |
| Trial Acronym |
PSAH |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VIRENDRA KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Dr. RMLIMS |
| Address |
ADMINISTRATION BLOCK, DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE MEDICINE, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007232 |
| Fax |
|
| Email |
virendrasankhwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VIRENDRA KUMAR |
| Designation |
PROFESSOR |
| Affiliation |
Dr. RMLIMS |
| Address |
ADMINISTRATION BLOCK, DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE MEDICINE, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007232 |
| Fax |
|
| Email |
virendrasankhwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HEMANT AGARWAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
ROOM 626, DR SC RAI HOSTEL, DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES, GOMTI NAGAR, LUCKNOW
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
9997057777 |
| Fax |
|
| Email |
hemantagarwal4028@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
|
|
Primary Sponsor
|
| Name |
DR RAM MANOHAR LOHIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
GOMTI NAGAR, LUCKNOW |
| 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 |
| Dr Virendra Kumar |
Dr. RML institute of medical sciences |
OT complex
Dr. RMLIMS, vibhuti khand, gomti nagar.
Lucknow
UTTAR PRADESH |
8176007232
virendrasankhwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics committee, Dr. Ram Manohar Lohia Institute of medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients more than 18-65 years of age with American Society of Anesthesiologists’ (ASA) physical status 1 or 2 who will be schedule for elective surgery under spinal anaesthesia in the supine position |
|
| ExclusionCriteria |
| Details |
1) BMI more than 30 kg/m2,
2) taking angiotensin converting enzyme inhibitors,
3) pregnant women,
4) emergency cases,
5) absolute or relative contraindications to spinal anaesthesia,
6) patients scheduled for unilateral spinal anaesthesia
7) failure to perform spinal anaesthesia.
8) patients with a baseline arterial SBP less than 90mmHg or mean arterial blood pressure (MBP) less than 70mmHg.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the predictive values of ultrasonographic inferior vena cava collapsibility index, caval aorta index & perfusion index as predictors for post spinal anaesthesia hypotension. |
BASE LINE, EVERY 2 MIN TILL 30 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic parameters blood pressure mean arterial pressure heart rate |
post spinal anaesthesia patient is observed for a period of 30 min & non invasive blood pressure mean arterial blood presure and heart rate are taken every 2 min from giving spinal anaesthesia to 30 min post spinal anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
04/08/2023 |
| 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
|
Sonographic
determination of inferior vena cava collapsibility index (IVCCI) and IVC to
aorta diameter index (IVC : Ao index) was introduced into clinical practice for
assessment of intravascular volume in many studies and reported to be reliable,
non-invasive and easy techniques for evaluating volume status, and can be
obtained by practitioners with little experience in echocardiography. Perfusion
index (PI) is a novel vital parameter that estimates the pulsatility of blood
in the extremities, which depends upon the amount of red and infrared light
absorption measured by a pulse oximeter. Perfusion index compares the pulsatile
blood flow to non-pulsatile blood flow in the peripheral vessels. Perfusion
index is reciprocally related to the vascular tone. A lower PI denotes a higher
peripheral vascular tone. Therefore, increased incidence of reduction in blood
pressure (BP) following SAB reflects the higher baseline PI. |