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CTRI Number  CTRI/2025/02/080642 [Registered on: 17/02/2025] Trial Registered Prospectively
Last Modified On: 25/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A RANDOMIZED CONTROLLED TRIAL COMPARING EFFECTS ON BLOOD PRESSURE OF PREGNANT PATIENTS UNDERGOING C-SECTION AND ON BLOOD PH ON NEWBORN NEONATES AFTER ADMINISTRATION OF INJECTION EPHEDRINE AND PHENYLEPHRINE DURING SPINAL ANAESTHESIA FOR C-SECTION 
Scientific Title of Study   A RANDOMIZED CONTROLLED TRIAL COMPARING MATERNAL AND NEONATAL EFFECTS OF BOLUS ADMINISTRATION OF EPHEDRINE AND PHENYLEPHRINE DURING SPINAL ANAESTHESIA FOR 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. Varshali Keniya 
Designation  Professor,  
Affiliation  Bharati Vidyapeeth Deemed to be University Medical College 
Address  Bharati Vidyapeeth Deemed to be University Medical College, Pune-Satara road, Dhankawadi, Pune,Maharashtra, India 411043

Pune
MAHARASHTRA
411043
India 
Phone  9881419089  
Fax    
Email  varshkeniya@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Varshali Keniya 
Designation  Professor 
Affiliation  Bharati Vidyapeeth Deemed to be University Medical College 
Address  Bharati Vidyapeeth Deemed to be University Medical College, Pune-Satara Road, Dhankawadi, Pune, Maharashtra, India 411043

Pune
MAHARASHTRA
411043
India 
Phone  9881419089  
Fax    
Email  varshkeniya@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. Rutwij Raut 
Designation  Junior Resident 
Affiliation  Bharati Vidyapeeth Deemed to be University Medical College 
Address  Room no. 604, PG Boys Hostel, Bharati Vidyapeeth Deemed to be University Medical College, Pune-Satara Road, Dhankawadi, Pune, Maharashtra 411043

Pune
MAHARASHTRA
411043
India 
Phone  9822020563  
Fax    
Email  rutwij47@gmail.com  
 
Source of Monetary or Material Support  
Bharati Hospital and Research Centre, Pune-Satara road, Dhankawadi, Pune, Maharashtra, India 411043  
 
Primary Sponsor  
Name  Bharati Hospital and Research Centre 
Address  Bharati Hospital and Research centre, Dhankwadi, Pune, 411043 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
Bharati Hospital and Research centre  Bharati Hospital and Research centre, Dhankwadi, Pune, 411043  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrRUTWIJ RAUT  Bharati Hospital and Research centre  ANAESTHESIA DEPARTMENT,3rd floor,old block -Bharati Hospital and Research centre, Dhankwadi, Pune, 411043 MAHARASHTRA
Pune
MAHARASHTRA 		 9822020563

rutwij47@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O82||Encounter for cesarean delivery without indication,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj.Epinephrine 6mg bolus  Every patient posted for Caeserean section surgery will be selected based on selection criteria and randomly divided into two groups of 28 each by using Envelope method(Research Randomizer),namely Group A, Group B. GroupA- will receive Inj Ephedrine 6mg bolus whenever systloic pressure falls more than 20% from baseline GroupB-will receive Inj Phenylephrine 100mcg bolus whenever systloic pressure falls more than 20% from baseline 
Comparator Agent  Inj.Phenylephrine 100mcg bolus  Every patient posted for Caeserean section surgery will be selected based on selection criteria and randomly divided into two groups of 28 each by using Envelope method(Research Randomizer),namely Group A, Group B. GroupA- will receive Inj Ephedrine 6mg bolus whenever systloic pressure falls more than 20% from baseline GroupB-will receive Inj Phenylephrine 100mcg bolus whenever systloic pressure falls more than 20% from baseline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  46.00 Year(s)
Gender  Female 
Details  1)Patients undergoing elective lower segment caesarean section
2)American Society of Anaesthesiologists (ASA) Grade II 
 
ExclusionCriteria 
Details  1)Patients not willing to participate in the study
2)Patients with pre-existing or pregnancy-induced hypertension, diabetes mellitus, known cardiovascular or cerebrovascular disease.
3)Patients with fetal abnormalities.
4)Patients indicated for LSCS i/v/o fetal distress.
5)Patients with any known hypersensitivity to any of the study drug.
6)Patients contraindicated to central neuraxial blocks
 
 
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 compare the effect on neonatal cord blood PH after the administration of bolus doses of Ephedrine and Phenylephrine.  Intraoperative duration 
 
Secondary Outcome  
Outcome  TimePoints 
1)To compare maternal blood pressure and heart rate with administration of bolus doses of Ephedrine and Phenylephrine.
2)To compare effects on neonatal cord blood glucose levels after administration of bolus doses of Ephedrine and Phenylephrine.
 		 Intraoperative duration 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   18/02/2025 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  email-rutwij47@gmail.com

  6. For how long will this data be available start date provided 06-09-2024 and end date provided 05-07-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

·       After obtaining approval from the institutional ethical committee, informed consent will be taken from all patients in a language understood by them.

·       All the patients will be kept nil by mouth for 6 hours prior to surgery, for solids, 2 hrs for liquids.

·       On the day of surgery patients will be brought to the operation theatre and divided into two groups.

·       Group allocation will be based on randomised sequence in which both assessor and patients will be blinded to group allocation by sealed envelope method.

·       Before induction of anaesthesia, patient will be given ringer lactate solution (10ml/kg), 3 lead ECG attached, baseline blood pressure, mean arterial blood pressure, saturation, heart rate will be recorded in each patient. Standard monitoring of pulse rate, systolic, diastolic and mean blood pressure and saturation will be done intra-operatively.

·       The patient will receive central neuraxial block by an expert anaesthesiologist. With the patient in the sitting position, 2.2 ml of 0.5% hyperbaric Inj.Bupivacaine with 30 mcg Inj.Buprenorphine will be injected intrathecally at L3-4 via a 25-gauge Quincke spinal needle. Patients will be then immediately turned supine and positioned with left uterine displacement.

·       Sensory loss assessment will be done with wet gauze method.

·       Additional boluses of similar dosage would be  administered whenever the systolic pressure decreases more than 20% from baseline.

·       Heart rate and blood pressure will be recorded immediately post- Spinal block and then at 1,3,5 min after it and later after every 5 min till delivery and then after every 15 min until the surgery ends.

·       Arterial blood samples will obtained from a double-clamped segment of umbilical cord and analysed within 10 min. Neonatal cord blood pH and glucose levels will be noted.

·       Any additional drugs if given, will be noted.

·       Complications in the form of an allergic reaction, nausea, vomiting, dizziness, diminished consciousness will be noted.

·       Requirement to conversion to general anaesthesia or need for supplementary rescue block or local infiltration by surgeon will be noted.

 
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