| CTRI Number |
CTRI/2024/04/065640 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
11/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Mother,Height weight,fetal and newborn weight on the effect of post spinal Anaesthesia decrease blood pressure |
|
Scientific Title of Study
|
Effect of Maternal BMI Fetal & newborn weight on the incidence of post spinal anaesthesia hypotension in full term Parturients undergoing elective caeserean section: A prospective observational 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 Aarti Agarwal |
| Designation |
Additional professor |
| Affiliation |
SGPGIMS LUCKNOW |
| Address |
Department of anaesthesiology room no 4 1st Floor A Block Sajay Gandhi Post Graduate Institute Of Mediacal Science Lucknow Raebarely Road Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226014 India |
| Phone |
8765974039 |
| Fax |
|
| Email |
aarti_agarwal000@yahoo.co.uk |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Aarti agarwal |
| Designation |
Additional professor |
| Affiliation |
SGPGIMS LUCKNOW |
| Address |
Department of Anaesthesiology Roomno - 4 1st floor A block SGPGIMS LUCKNOW Uttar Pradesh Raebareli Road Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226014 India |
| Phone |
8765974039 |
| Fax |
|
| Email |
aarti_agarwal000@yahoo.co.uk |
|
Details of Contact Person Public Query
|
| Name |
Dr Anil Kumar |
| Designation |
Junior resident |
| Affiliation |
SGPGIMS LUCKNOW |
| Address |
SGPGIMS hostel room no -706
seventh floor M1 Block LUCKNOW Raiberily Road Lucknow Uttar Pradesh Lucknow UTTAR PRADESH 226014 India |
| Phone |
993610637 |
| Fax |
|
| Email |
anil.medico48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institute Of Medical Science, Lucknow |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute Of Medical Science |
| Address |
Raeberily Road Lucknow Uttar Pradesh Pin Code- 226014 |
| 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 Aaarti Agarwal |
Sanjay Gandhi Postgraduate Institute Of Medical Science Medical Science Lucknow |
Department Of Anaesthesiology 1st Floor Block A Room No- 15 Lucknow UTTAR PRADESH |
8765974039
aarti_agarwal000@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SGPGIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
American Society of Anaesthesiologists status II
Women of child bearing age Below 40year
BMI less than 40
Height between 150-180 cm
Non-laboring
At term with singleton uncomplicated pregnancies
With no gross comorbidities
With longitudinal lie scheduled for elective caesarean delivery under spinal
anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient’s refusal for regional
anaesthesia
Women with obstetric conditions that may affect the severity of Aorto Caval compression, such as transverse lie, fetal macrosomia, uterine abnormalities (e.g.,large fibroids, bicornuate uterus) and polyhydramnios
Women with a hypertensive disorder or any condition associated with autonomic
neuropathy (e.g., diabetes mellitus for than 10 yrs), with renal failure, or currently
smoking or with illicit drug use
Those with kyphosis and scoliosis
Sepsis at the site of the injection
Indeterminate neurological disease
Coagulopathy
Increased intracranial pressure
History of allergy to local anaesthetics
Discopathy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess the effect of maternal BMI,Fetal & Newborn weight on the incidence of post spinal anaesthesia hypotension in full term parturients undergoing elective ceasarean section |
Systolic and Diastolic Blood
Pressure recorded ,After spinal anaesthesia to til delivery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Effect on Mean phenylephrine consumption
Umbilical cord blood ph & base excess |
After spinal anaesthesia to till delivery
After clamp of umlical cord |
|
|
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)
|
22/04/2024 |
| 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 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
|
Spinal anesthesia is well tolerated , it still is associated with considerable side effect ,most common being hypotension due to sympatholysis , is occurring in upto 75% of cases,potentially endangerous to both mother and fetus. Spinal block leads to sympatholysis ,may leads to vasodialation and consequentally cause maternal hypotension , which compromise uterine blood flow and fetal circulation and cause fetal hypoxia ,bradycardia and acidosis. Incidence of hypotension in genral population 25-75% and even higher in parturient due to physiological change in pregnancy that cause compression in inferior venae cava by hypertrophic uterus and also due to collateral venous plexus in epidural space , the physiological change in epidural space result in increase pressure of cerebrospinal fluid in lumbosacral area which result in cephalod spread of local anaesthestics these case rapid onset of sympatholysis due to increase sensitivity of nerve fiber to local anaesthetics during pregnancy . Higher sensitivity of nerve fiber towards local anaesthetics and aorto cavel compression of pregnant ueterus ,are rthe main reason for the increase incidence and higher level of hypotension in pregnant women as compare to non pregnant women, Pregnant women have increase sympathetic activity as compare to parasympathetic , then sympatholytic activity may leads to higher degree of vasodialatation ,consequntally decrease venous return , cardiac preload , bradycardia nausea and vomiting in mother The Duration of hypotension play importance role than its severity , hypotension <2 minute didn,t affect neurodevlopment outcome , whereas maternal hypotension lasting >4 minute neurodevlopment in first week of life and may persist through life long. A Number of measurement and treatment are use in clinicle practice in spinal anasthesia induce hypotension as – -Preloading and coloading with colloid -Compressing of lower limb with compression stocking or bandage -Administration of optimal dose of local anasthetics -left tilt positioning - adminastration of ionotrops and vessopressure, phenylephrine is preferred which associated with lower incidence of fetal acidemia ,nausea and vomiting Thus identification of multifactor of spinal anasthesia induce hypotension. Might help to prevent them dramatic consequnces in mother and fetus. Thus through this study we observe the effect of maternal BMI fetal and newborn weight on hypotension by observe 100 sample patient 12 month in pmssy building sgpgi lucknow. After ethical comettie approval and CTRI registration. |