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CTRI Number  CTRI/2024/07/070174 [Registered on: 08/07/2024] Trial Registered Prospectively
Last Modified On: 08/07/2024
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 intravenous fluid given before and during spinal anaesthesia on incidence of fall of blood pressure in cesarean delivery 
Scientific Title of Study   Comparative study of pre-loading and co-loading with crystalloids on the incidence of hypotension after spinal anaesthesia in cesarean delivery 
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 MD Imran 
Designation  Postgraduate resident in anaesthesiology 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9739614947  
Fax    
Email  md.imranbrims2014@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhavana Raval 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9426373182  
Fax    
Email  drbhavanaraval@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhavana Raval 
Designation  Professor(H.G) 
Affiliation  B.J. Medical College and Civil Hospital , Ahmedabad 
Address  F3, First floor, Department of anaesthesiology, Civil hospital, Asarwa, Ahmedabad Ahmadabad GUJARAT 380016 India

Ahmadabad
GUJARAT
380016
India 
Phone  9426373182  
Fax    
Email  drbhavanaraval@yahoo.com  
 
Source of Monetary or Material Support  
B.J.Medical College and Civil Hospital asarwa Ahmedabad 380016, Government of Gujarat, India 
 
Primary Sponsor  
Name  BJMedical College and Civil Hospital Ahmedabad Government of Gujarat 
Address  7 th floor, Health and family welfare department , Sachivalay, Gandhinagar 382016,India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 MD Imran  B.J.Medical College and Civil Hospital , Ahmedabad  Department of anaesthesia, obstetric operation theatre ,ground floor, 1200 bed hospital, Asarwa, Ahmedabad 380016 Ahmadabad GUJARAT
Ahmadabad
GUJARAT 		 9739614947

md.imranbrims2014@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee , B.J.Medical College and Civil Hiospital , Ahmedabad  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  15ml/kg Ringers Lactate given before spinal anaesthesia   To record the incidence of hypotension when Ringers Lactate given before spinal anaesthesia in a Parturient undergoing elective cesarean section  
Comparator Agent  15ml/kg Ringers Lactate given during spinal anaesthesia  To record the incidence of hypotension when Ringers Lactate given during spinal anaesthesia in a parturient undergoing elective cesarean section 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  parturients of ASA grade I/II posted for elective cesarean delivery giving consent for study.  
 
ExclusionCriteria 
Details  Patient refusal, Patients with pre-existing stenotic heart disease, Known case of eclampsia, Known case of neurological disorder, History of allergy to local anaesthetics, Contraindications to spinal anaesthesia, Patients with history of bleeding disorders or on anticoagulant therapy, ASA grade IV/V
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
parameters compared will be SBP,DBP,MAP,PR,RR and SPO2   parameters measured every 2min till 10min,every 5min till 30min ,every 15min till the end of surgery and then hourly till 24hours  
 
Secondary Outcome  
Outcome  TimePoints 
Total dose of atropine required ,
Total dose of mephentermine required,
Incidence of nausea/vomiting,
APGAR SCORE
 		 24hours post operative 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 3 
Date of First Enrollment (India)   16/07/2024 
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  

Hypotension after spinal anaesthesia is a complication that occurs in general population and in patients undergoing cesarean section .this hypotension is mainly due to sympathetic blockade which causes peripheral vasodilation and venous pooling. The risk of hypotension increases in pregnant women undergoing cesarean section that requires block levels as high as 4th thoracic segment dermatome. In addition, the risk of hypotension is also increased due to anatomic and physiological changes in pregnant women with aortocaval compression. Hypotension can cause adverse effects on both mother and foetus. Several techniques and methodologies have been adopted for the prevention of this neuraxial hypotension with varying degree of success. The administration of intravenous fluids to optimize the blood volume during sympathectomy has been the most popular and widely used as the first line of therapy. The intravenous fluids can be used both before and during the administration of spinal anaesthesia, the techniques appropriately named as pre-loading and co-loading respectively.

 
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