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CTRI Number  CTRI/2024/07/070622 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 15/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of Anthropometric Parameters on spinal anaesthesia and Hemodynamic changes in pregnant women undergoing cesarean section  
Scientific Title of Study   The Effect Of Anthropometric Parameters On Subarchnoid Block Characteristics And Hemodynamics In Parturients Undergoing Lower Segment Cesarean Section (LSCS)- 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 Niveditha S 
Designation  Junior Resident  
Affiliation  Rajarajeswari Medical College and Hospital  
Address  Department of Anesthesiology Rajarajeswari Medical College and Hospital Kambipura, Mysore Road , Bangalore, Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9844403622  
Fax    
Email  nivedithagowda456@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sowmya M J 
Designation  Professor  
Affiliation  Rajarajeswari Medical College and Hospital  
Address  Department of Anesthesiology Rajarajeswari Medical college and Hospital Kambipura,Mysore road , Bangalore Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sowmya M J 
Designation  Professor  
Affiliation  Rajarajeswari Medical College and Hospital  
Address  Department of Anesthesiology Rajarajeswari Medical college and Hospital Kambipura,Mysore road , Bangalore Karnataka

Bangalore
KARNATAKA
560074
India 
Phone  9880574092  
Fax    
Email  drsowmyamj80@gmail.com  
 
Source of Monetary or Material Support  
Rajarajeswari Medical College and Hospital Kambipura, Mysore Road Bangalore Karnataka 560074 
 
Primary Sponsor  
Name  Rajarajeswari Medical College and Hospital  
Address  Kambipura , Mysore Road Bangalore, Karnataka 560074 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Niveditha S  Rajarajeshwari medical college and hospital   2nd floor department of anaesthesia kambipura Mysore Road Bangalore Karnataka 560074
Bangalore
KARNATAKA 
9844403622

nivedithagowda456@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Rajarajeswari Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Parturients with American Society of Anesthesiologists(ASA)1 and 2 status undergoing elective LSCS under sub arachnoid block and willing to give consent will be included. 
 
ExclusionCriteria 
Details  Parturients undergoing LSCS under general anaesthesia.
Parturients undergoing emergency LSCS.
Patients receiving intrathecal additives.
Any contraindication to spinal Anaesthesia.
Multiple gestation,gestational diabetes mellitus,polyhydramnios.
History of spinal deformity or spine surgery.
Patients refusing to participate in the study.
ASA3/4. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the effects of the anthropometric parameters on the spread of spinal anaesthesia with respect to time taken to achieve T4 level and the maximum level blockade achieved by finding the correlation coefficient.  0,1,2,3,4,5,7,9,11,13,15 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To determine the effects of the anthropometric measurements on heart rate and blood pressure.
To compare the drug dose given conventionally with height weight based formula. 
0,1,2,3,4,5,7,9,11,13,15 minutes. 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   26/07/2024 
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="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  
When selecting the anesthesia method in cesarean operations, attention must be paid to the
urgency of the operation, pre-existing maternal systemic problems, general status of the
fetus,and the surgeon’s and patient’s preference. Although general or regional anaesthesia
can be used in lower segment Caesarean section (LSCS), regional anesthesia is the most
widely preferred anaesthesia method for caesarean sections in developed countries.
Regional anaesthesia offers many advantages to the mother like,awake mother during the
labour, very little or no requirement for airway intervention, protection of airway reflexes,
reduced blood loss, reduced probability of drug-related fetal depression, and the
continuation of analgesia in the postoperative period.
There is a greater tendency of high level of sensory blockade in parturients with spinal
anaesthesia. Pregnant patients display higher sensitivity to local anaesthetics. Neuraxial
blockage forms at low concentration of local anaesthetics. A decreased lumbosacral
subarachnoidal space volume is a major factor in the cephalad intrathecal spread of local
anesthetics in term parturients and their subarachnoidal space is decreased due to the
compressive effect of huge uterus.
There is greater amount of epidural tissue in parturients, the epidural veins are widened and
the epidural space is narrowed, therefore there is a need for 25-30% less local anaesthetics
in spinal and epidural anaesthesia. In circumstances that lead to increased intra abdominal
pressure or widening of epidural veins, generally high levels of blocks are induced.
Abdominal circumference(AC) correlates with intra abdominal volume, maternal AC
increases during pregnancy and it is influenced by fetus size, amniotic fluid, size of the
uterus.
Increased height of block can lead to high spinal anaesthesia, hypotension and respiratory
depression. However, low level of blockade can lead to inadequate anesthesia and patient
discomfort. Although it is considered safe anaesthetic method, nausea and vomiting are
reported after spinal anaesthesia despite prehydration and left displacement of uterus. This
is attributed to greater aortio caval compression and greater cephaloid spread of sensory blockade by an enlarged uterus.
Hence various parturient factors such as height, body mass index(BMI), body surface
area(BSA), abdominal circumference (AC), Waist hip ratio, symphysis fundal height
(SFH), baby weight, vertebral column length may influence the spread of spinal anaesthesia
and have been studied individually to know their effects with variable results.
Hence we planned a study to know the effect of the anthropometric factors on the block
characteristics after subarachnoid block in parturients undergoing elective LSCS.
 
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