| CTRI Number |
CTRI/2024/02/063275 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
21/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To know if Body Mass Index (BMI) and Hypotension following spinal anaesthesia in Caesarean section is related |
|
Scientific Title of Study
|
A Study to Evaluate the Relationship between Body Mass Index (BMI) and Hypotension following Spinal Anaesthesia in Caesarean Section |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhra Pradhan |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care.
Gauhati Medical College and Hospital.
Guwahati.
Kamrup
ASSAM
781032
India |
| Phone |
9874621653 |
| Fax |
|
| Email |
subhrapradhancom@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Trina Sen |
| Designation |
Assistant Professor |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care.
Gauhati Medical College and Hospital.
Guwahati.
Kamrup
ASSAM
781032
India |
| Phone |
9707642773 |
| Fax |
|
| Email |
trinasen8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhra Pradhan |
| Designation |
Post Graduate Trainee |
| Affiliation |
Gauhati Medical College and Hospital |
| Address |
Department of Anaesthesiology and Critical Care.
Gauhati Medical College and Hospital.
Guwahati.
Kamrup
ASSAM
781032
India |
| Phone |
9874621653 |
| Fax |
|
| Email |
subhrapradhancom@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Gauhati Medical College and Hospital |
| Address |
Guwahati - 781032
Assam
India |
| 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 Subhra Pradhan |
Gauhati Medical College and Hospital |
Department of Anaesthesiology and Critical Care
Kamrup
ASSAM |
9874621653
subhrapradhancom@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE OF GAUHATI MEDICAL COLLEGE & HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1.Pregnant women between the age 18 years-45 years
2.Elective LSCS cases
3.ASA II status
4.Patients giving consent for the study
5.Singleton Pregnancy
6.Gestational age more than equals to 35 weeks |
|
| ExclusionCriteria |
| Details |
1.Patients not giving consent
2.Patients hemodynamically unstable
3.Imminent fetal or maternal health risk
4.Failed spinal
5.Patients with Hypertension, PIH, Preeclampsia, Eclampsia
6.Patients with anti-coagulants use, thrombocytopenia, bleeding disorders, history of cardiovascular diseases
7.Patients not having antenatal USG. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the correlation between Body Mass Index (BMI) and incidence of episodes of hypotension following spinal anaesthesia in caesarean section |
Baseline, 0,3,6,9,12,15,18 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the total doses of vasopressors used in between two groups.
2.To compare the total volume of intravenous fluid used in between two groups
|
0,3,6,9,12,15,18 mins |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
01/03/2024 |
| 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="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
|
Hypotension after spinal anaesthesia is more
prominent in parturient than in general population due to many factors; for example
- physiological changes in pregnancy, patient factors like nutritional status, Body
Mass Index (BMI), drug factors like dose, lumber puncture space [i] [ii] etc. There are very few studies that looked into the
relationship of BMI and spinal hypotension. The present study aims to evaluate
the correlation of hypotension according to the BMI.Patients
will be divided into two groups- Eutropia group with BMI <25 and Overweight
group with BMI ≥25.
After
arrival to OT, patient would be prepared for standard monitoring- NIBP, ECG, Pulse
oximetry and 18G IV cannula will be given. Three readings of blood pressure
will be taken 3 minutes apart and average will be taken as baseline BP. With
all aseptic precautions Lumber Puncture will be done in L4-L5 intervertebral
space in left lateral position using 25G Quincke’s lumbar puncture spinal needle
and free flow of CSF will be noted. Then injection hyperbaric Bupivacaine [Dose:12mg]
and injection Buprenorphine(60mcg) will be given slowly. Spinal sensory block
height will be assessed bilaterally in mid axillary line by cold sensation
using alcohol swab and motor block height will be assessed by Modified Bromage
Scale. A failure will be reported if T6 sensory block not achieved after 15
mins of intrathecal injection. Co-loading of lactated Ringer’s solution will be
infused for a total of 10 ml/kg until delivery. In presence of hypotension a
bolus of 6 mg of Ephedrine or 100 mcg of Phenylephrine will be used whichever
considered appropriate. Oxygen at a rate of 5L/min will be administered via
face mask.
Blood pressure
monitoring will be done every 3 mins interval until the delivery of the
shoulder of the baby and volume of crystalloids infused and total doses of
vasopressors will be recorded.
[i]
van Bogaert LJ. Lumbar lordosis and the spread of
subarachnoid hyperbaric 0.5% bupivacaine at cesarean section. Int J Gynaecol
Obstet. 2000 Oct;71(1):65-6. doi: 10.1016/s0020-7292(00)00203-4. PMID:
11044545.
[ii]
Hocking G, Wildsmith JA. Intrathecal drug spread.
Br J Anaesth. 2004 Oct;93(4):568-78. doi: 10.1093/bja/aeh204. Epub 2004 Jun 25.
PMID: 15220175
|