| CTRI Number |
CTRI/2023/07/055498 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of fluid administration guided by ultrasound of neck vessels versus routine fluid administration for prevention of low blood pressure following spinal anaesthesia in pregnant patient for caesarean section. |
|
Scientific Title of Study
|
Comparative evaluation of Internal Jugular Vein Collapsibility Index guided versus conventional crystalloid administration on post spinal hypotension in parturients undergoing 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 |
Dr Anurag Singh |
| Designation |
Postgraduate Student |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital. |
| Address |
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated Lok Nayak Hospital,
New Delhi
DELHI
India
Central
DELHI
110002
India |
| Phone |
7987201149 |
| Fax |
|
| Email |
as899270@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munisha Agarwal |
| Designation |
Director Professor and Head of Department |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College and Associated lok nayak hospital
New Delhi
DELHI
India
Central
DELHI
110002
India |
| Phone |
9968604216 |
| Fax |
|
| Email |
munisha.agarwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Singh |
| Designation |
Postgraduate Student |
| Affiliation |
Maulana Azad Medical College and Lok Nayak Hospital |
| Address |
Department of Anaesthesiology and Intensive care, Maulana Azad Medical College and associated Lok Nayak Hospital,
New Delhi
DELHI
Central
DELHI
110002
India |
| Phone |
7987201149 |
| Fax |
|
| Email |
as899270@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Lok Nayak Hospital. |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Lok Nayak Hospital. |
| Address |
Department of Anaesthesiology and Intensive Care, Maulana Azad Medical College, New Delhi- 110002 |
| 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 Anurag Singh |
Maulana Azad Medical College and Lok Nayak Hospital |
OT Blocks, Maulana Azad Medical College and Lok Nayak Hospital.
New Delhi- 110002
DELHI
Central
DELHI |
7987201149
as899270@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional fluid administration before spinal anesthesia |
Before administration of spinal anaesthesia, intravenous fluid will be administered @12 ml/kg over 15 minutes. |
| Intervention |
Intravenous fluid administration before spinal anaesthesia , based on Internal jugular vein collapsibility index. |
Before administration of spinal anaesthesia, Ultrasonographic assessment of internal jugular vein will be done to calculate collapsibility index and guide fluid administration accordingly based on index.If index comes out to be more than 39%, fluid will be given@5ml/kg bolus over 5 minutes, and then index will be reassesed . If index still more than 39%, second bolus of fluid will be given@3ml/kg over 5 minutes and subsequent boluses of 3ml/kg fluid will be given until index becomes less than 39%. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients of American Society of Anesthesiologists(ASA) Physical status 2.
2. Term, singleton pregnancy
3. Height of the patient ( 150- 170) cms. |
|
| ExclusionCriteria |
| Details |
1.
Absolute contraindications for spinal anaesthesia -localized sepsis,deranged coagulation profile,severe hypovolemia, severe aortic stenosis, severe mitral stenosis.
2. Relative contraindications for spinal anaesthesia- pre existing neurological deficits, severe spinal deformity.
3. Significant hepatic, renal or cardiovascular disease. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the incidence of post spinal hypotension |
BP measurement will be done every 2 minutes for the first 15 minutes after spinal anaesthesia followed by every 5 minutes till the end of surgery to assess hypotension |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Amount of crystalloid administered before spinal block.
2.Number of episodes of hypotension
3.Total requirement & dose of vasopressor.
4. Total amount of fluid administered after spinal block till cord clamping.
5. APGAR score of the baby at 1 minute & 5 minutes.
|
1.From iv cannulation to administration of spinal block
2. BP measurement will be done every 2 minutes for the first 15 minutes followed by every 5 minutes till end of surgery to estimate number of times hypotension occurs after spinal block
3. From administration of spinal block till completion of surgery
4. Time between administration of spinal block & cord clamping.
5.At 1 minute & 5 minutes after delivery of baby. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/08/2023 |
| 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="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 anaesthesia is the anaesthetic techniqueof choice for caesarean section. The most common side effect of spinal anaesthesia is hypotension and has a very high incidence rate.It is caused by spinal block induced sympatholysis which leads to vasodilation and thereby hypotension. The administration of intravenous fluids to optimise the blood volume during sympathectomy has been widely used as first line therapy. Ultrasound has been used to estimate the pre-operative intravascular volume status. Internal jugular vein is an easily accessible vessel for assessment of intravascular fluid volume .Thus, we plan to undertake this study to evaluate and compare internal jugular vein collapsibility index guided versus conventional crystalloid administration on post spinal hypotension in pregnant patients undergoing caesarean section.
The study will be conducted in the Department of Anaesthesiology, Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi. In this study, pregnant patients aged between 18- 40 years scheduled for elective caesarean section will be recruited.
Primary objective of the study is to evaluate the incidence of post spinal hypotension whereas secondary objective is to evaluate the amount of crystalloid administered before spinal block, to evaluate the number of episodes of hypotension, vasopressor requirement, and total amount of fluid administered till cord clamping and to evaluate the APGAR score of the baby at 1 minute and 5 minutes.
|