| CTRI Number |
CTRI/2024/03/064769 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
25/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two doses of Phenylephrine in prevention of Oxytocin induced hemodynamic changes in Caesarean Section under Spinal Anaesthesia: A Randomized Control Trial |
|
Scientific Title of Study
|
"Comparison of two doses of Phenylephrine in prevention of Oxytocin induced hemodynamic changes in Caesarean Section under Spinal Anaesthesia: A Randomized Control Trial" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepesh Sharma |
| Designation |
Junior Resident |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rohikhand medical college and hospital,
bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9760949833 |
| Fax |
|
| Email |
deepeshsharma1996@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ankur Garg |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rohikhand medical college and hospital,
bareilly
Bareilly UTTAR PRADESH 243006 India |
| Phone |
9650715363 |
| Fax |
|
| Email |
ankurgarg.gsvm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ankur Garg |
| Designation |
Associate Professor |
| Affiliation |
Rohilkhand Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Rohikhand medical college and hospital,
bareilly
UTTAR PRADESH 243006 India |
| Phone |
9650715363 |
| Fax |
|
| Email |
ankurgarg.gsvm@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
|
|
Primary Sponsor
|
| Name |
rohilkhand medical college |
| Address |
Department of Anaesthesia, Rohilkhand Medical College and Hospital |
| Type of Sponsor |
Private 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 Ankur Garg |
Rohilkhnd Medical College and Hospital |
Department of Anaesthesiology,
Rohilkhand medical college and hospital,
bareilly u.p. Bareilly UTTAR PRADESH |
9650715363
ankurgarg.gsvm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE ROHILKHAND MEDICAL COLLEGE AND HOSPITAL BAREILLY UP |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJ. PHENYLEPHERINE 50 MCG |
After the co-administration of Oxytocin and Phenylephrine via intravenous route, the heart rate, systolic, diastolic, mean blood pressure and oxygen saturation will be recorded. |
| Comparator Agent |
INJ. PHENYLEPHERINE 75 MCG |
After the administration of Oxytocin and co-administration of Phenylephrine, the heart rate, systolic, diastolic, mean blood pressure and oxygen saturation will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1) ASA Grade II
2) Age group 20- 40yrs20
|
|
| ExclusionCriteria |
| Details |
•ASA Grade III or IV
•Patients with obstetrical complications like :-
oantepartum haemorrhage
opregnancy induced hypertension
ocord complications (nuchal cord or cord prolapse)
ofoetal malformations
oPolyhydramnios
•Any contraindication to spinal anaesthesia present in patient.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To analyze efficacy between two doses of Phenylephrine.
•To compare the incidence of adverse effects between two doses of Phenylephrine. |
At 2,4,6,8,10 minutes after the administration of Oxytocin and co-administration of Phenylephrine, the heart rate, systolic, diastolic, mean blood pressure and oxygen saturation will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NONE |
NONE |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="62"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
04/04/2024 |
| 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 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
|
The Caesarean section, a crucial procedure in
obstetrics, is the best way to successfully deliver a foetus in a number of
circumstances. 1 In order to get the best results and give the
expectant mother a safe and comfortable labouring experience, a team approach
is essential. It’s critical to identify
the anaesthesia type that has minimal negative effects on mother and foetus.
The type of anaesthesia chosen for LSCS is
dependent on many factors such as the urgency, the reason why LSCS is being
performed, preference of the parturient as well as coexisting medical problems. There are numerous reasons to use
general anaesthesia including life-threatening foetal compromise, unsuccessful
regional anaesthesia, contraindication to local anaesthesia, when the regional
anaesthesia might not have enough time to be used, maternal request. 2
Previously, general anaesthesia was considered to be the technique
of choice, but now, the number of LSCS done under general anaesthesia have
significantly reduced. 3 Securing an airway is more difficult in a
pregnant female than in the general population due to physiological and anatomical
changes occurring during pregnancy. 4 The obstetric airway may be
affected by anatomical changes such as oedema in the upper airway, breast
enlargement, and increase in weight. 4 A study done on parturient, shows that there is a link between a
decreased length of neck, obesity, a receding mandible, and prominent maxillary
incisors that makes intubation harder. 5 Aspiration of the gastric
contents is also one of the major concerns.
Throughout the past two decades, Lower Segment
Caesarean Section is being done under regional anaesthesia, this way the
problem of securing a difficult airway during general anaesthesia is being avoided. 2
Complimentary to the choice of anaesthesia, the development of comparatively safer
choices of local anaesthetics, such as Ropivacaine and Levobupivacaine have further
cemented the safety of Regional Anaesthesia as the choice of anaesthesia.
Although historically general anaesthesia has
been utilised when there is a threat to the mother or the foetus, while
neuraxial methods are recommended in less urgent situations, due to its
relative simplicity and quicker onset of effect, in cases of urgent caesarean
sections, spinal anaesthesia is advocated. It involves injecting local
anaesthetics into the subarachnoid space with a spinal needle. This
subarachnoid block is primarily administered between the L3 and L4 and L5
subarachnoid spaces.
Postpartum haemorrhage (PPH) is one of the leading causes of maternal
mortality with uterine atony being the cause in about 50% cases. 7
By using uterotonic drugs properly, it can be decreased. The most often
utilised uterotonic substance is oxytocin. The risk of PPH can be decreased by
up to 40% by regularly utilising oxytocin as a prophylactic measure. 8
Yet, because oxytocin acts on oxytocin receptors found in the heart and
major vessels, it has the unfavourable effect of causing hypotension and reflex
tachycardia.9 To treat this hypotension, various vasopressors such
as Ephedrine, Mephentermine and Phenylephrine are used. Among this, Phenylephrine has displayed a faster and
better control of blood pressure (BP) during spinal anaesthesia‑induced hypotension. 10
Phenylephrine an alpha agonist with a short duration of action that can
be administered as a bolus or as an
infusion at titrated dosages to treat oxytocin-induced hypotension. 11
Phenylephrine co-administration has been found to reduce the effects of oxytocin
on cardiac output, heart rate and systemic vascular resistance. 12
At higher doses Phenylephrine can cause reflex bradycardia along with decreased
cardiac output. 13
There are very few
studies which have discussed a minimum dose with a better efficacy of
phenylephrine, used during co-administration with oxytocin to reduce the
hemodynamic changes of oxytocin
Therefore current
study will be done to compare two different doses of phenylephrine which are
required to prevent adverse cardiovascular changes due to oxytocin in females
undergoing LSCS under spinal anaesthesia.
|