| CTRI Number |
CTRI/2021/02/031380 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
05/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different volumes of intravenous fluid administration after spinal anaesthesia for prevention of hypotension in elective caesarean section. |
|
Scientific Title of Study
|
COMPARISION OF TWO DIFFERENT VOLUMES OF CRYSTALLOID CO- LOADING ON
PREVENTION OF SPINAL ANAESTHESIA INDUCED HYPOTENSION DURING CAESAREAN
DELIVERY; A RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAshwini P |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute Of Medical Sciences,Ballari |
| Address |
Department of anaesthesiology
Vijayanagar Institute Of Medical Sciences, Cantonment,Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9108238514 |
| Fax |
|
| Email |
ashpatil25101994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAshwini P |
| Designation |
Junior Resident |
| Affiliation |
Vijayanagar Institute Of Medical Sciences,Ballari |
| Address |
Department of anaesthesiology
Vijayanagar Institute Of Medical Sciences, Cantonment,Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9108238514 |
| Fax |
|
| Email |
ashpatil25101994@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBala Bhaskar S |
| Designation |
Professor |
| Affiliation |
Vijayanagar Institute Of Medical Sciences,Ballari |
| Address |
Department of anaesthesiology
Vijayanagar Institute Of Medical Sciences, Cantonment,Ballari
Bellary
KARNATAKA
583104
India |
| Phone |
9880012349 |
| Fax |
|
| Email |
sbalabhaskar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute Of Medical Sciences |
| Address |
Cantonment,Ballari,583104 |
| 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 |
| Ashwini P |
Vijayanagar Institute Of Medical Sciences |
Department of anaesthesiology,Major OT complex,Vijayanagar Institute Of Medical Sciences, Ballari
Bellary
KARNATAKA |
9108238514
ashpatil25101994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijayanagar Institute Of Medical Sciences ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: Y838||Other surgical procedures as the cause of abnormal reaction of the patient, or of later complication, without mention of misadventure at the time of the procedure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous fluid- Ringers lactate |
Ringers lactate fluid administration to prevent spinal anaesthesia induced hypotension |
| Comparator Agent |
Two different volumes of Ringers lactate |
Comparison of two different volumes of Ringers lactate fluid administration for prevention of spinal anaesthesia induced hypotension. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Primiparous and multiparous parturient women with 37–42 weeks of gestation
1.Singleton pregnancy
Posted for elective caesarean section under spinal anaesthesia.
2.ASA grade II
3.Normal foetal profile
4.Patients only on maintenance flow of IV fluids |
|
| ExclusionCriteria |
| Details |
1.Contraindication for or refusal of spinal anaesthesia
2.Hypertension (SBP >140 mm Hg or DBP >90 mm Hg) due to Chronic or gestational hypertension or preeclampsia
3.Cardiovascular and/or cerebrovascular diseases
4.Diabetes mellitus
5.Hypersensitivity to fentanyl or bupivacaine
6.Obesity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effect of varying volumes of crystalloid co-loading in preventing hypotension in caesarean section under spinal anaesthesia.
|
After spinal anaesthesia.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the requirement of vasopressors, other haemodynamic changes, neonatal outcomes and others. |
After spinal anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
26/02/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Spinal anesthesia is considered the technique of choice for elective caesarean delivery due to its technical simplicity, safety, effectiveness and reduced cost. However, it commonly results in hypotension (incidence approximately 80%), which may have significant maternal and foetal adverse effects.Techniques such as fluid loading (crystalloid and colloid), vasopressor administration (α and β adrenergic agonists), lower limb compression, etc have been shown to decrease the incidence of spinal-induced hypotension (SIH) during caesarean section.Fluid co-loading appears to be more physiological and rational approach as the maximal effect can be achieved at the time of onset of the block. Crystalloids such as Ringer Lactate and Normal Saline have been found to be useful as co-load instead of preload in elective caesarean sections under spinal anaesthesia. |