FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 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  
Status 
Not Applicable 
 
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.


 
Close