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CTRI Number  CTRI/2026/01/102166 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 24/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effects of three different bolus doses of Norepinephrine for preventing low blood pressure during Spinal Anaesthesia for caesarean delivery. A Randomized Clinical Trial 
Scientific Title of Study   Effects of three different bolus doses of Norepinephrine for preventing Hypotension during Spinal Anaesthesia for caesarean delivery. A Randomized Clinical Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Deepali Srivastava  
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology Regional institute of Medical Sciences Imphal Manipur
Imphal Manipur
Imphal West
MANIPUR
795004
India 
Phone  9027671298  
Fax    
Email  doctordeepali.68@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Takhelmayum Hemjit singh 
Designation  Professor  
Affiliation  Regional institute of medical sciences  
Address  Department of Anaesthesia Regional institute of Medical Sciences Imphal Manipur
Department of Anaesthesia Regional institute of Medical Sciences Imphal Manipur
Imphal West
MANIPUR
795004
India 
Phone  9436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Deepali Srivastava  
Designation  Post graduate trainee 
Affiliation  Regional Institute of Medical Sciences  
Address  Department of Anaesthesia Regional Institute of Medical Sciences Imphal Manipur
Imphal Manipur
Imphal West
MANIPUR
795004
India 
Phone  9027671298  
Fax    
Email  doctordeepali.68@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesia Regional Institute Of Medical Sciences Imphal west Manipur 795004 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences  
Address  Department of Anaesthesia Regional Institute of Medical Sciences Imphal west Manipur  
Type of Sponsor  Government 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 Deepali Srivastava   Regional Institute Of Medical Sciences   Modular OT Complex Department of Anaesthesiology Regional Institute of Medical Sciences Imphal west
Imphal West
MANIPUR 
9027671298

doctordeepali.68@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board ,RIMS imphal  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O746||Other complications of spinal andepidural anesthesia during labor and delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Norepinephrine 10 Micrograms   Study participants will receive 10 micrograms of norepinephrine in case of hypotension induced during spinal anaesthesia for cesarean delivery.Duration of surgery is 45-90 minutes  
Comparator Agent  Norepinephrine 5 microgram  Study participants will receive 5 micrograms of norepinephrine in the event of hypotension induced during spinal anaesthesia for caesarean delivery.Duration of surgery is approximately 45 to 90 minutes 
Comparator Agent  Norepinephrine 8 micrograms  Study participants will receive 8 micrograms of norepinephrine in case of hypotension induced during spinal anaesthesia for cesarean delivery.Duration of surgery is approximately 45 to 90 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  AMERICAN SOCIETY OF ANAESTHESIOLOGISTS(ASA) PHYSICAL STATUS GRADE I OR II.
PATIENTS UNDERGOING ELECTIVE CAESAREAN DELIVERY 
 
ExclusionCriteria 
Details  1 History of allergy to local anaesthetic agent and or study drugs
2 Bleeding disorders like Von Willebrand disease Idiopathic Thrombocytopenic purpura platelet count less than 50000 per microlitre
prothrombin time less than 14 seconds
International normalised ratio INR less than 1.5
3 Local site infection mainly spine
4 Spinal deformity
5 Cardiac respiratory diseases and kidney disorder and neurological deficit
6 Parturient with Pre eclamptic toxaemia or any hypertensive disorder
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine the optimal bolus doses of norepinephrine in management of spinal hypotension in elective caesarean section  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic parameters like Systolic blood pressure (SBP) Mean arterial pressure (MAP) Diastolic blood pressure (DBP) & heart rate (HR) at varied time interval after administration of norepinephrine & also the foetal cord blood acid base study at delivery & after 5 minutes
Adverse effects like giddiness, nausea &vomiting.

 
At baseline & After 5 minutes till 90 minutes 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   15/02/2026 
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 - 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 - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [doctordeepali.68@gmail.com].

  6. For how long will this data be available start date provided 20-12-2025 and end date provided 20-12-2026?
    Response - Immediately following publication. No end date.

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

Spinal anaesthesia is the most common preferred type of anaesthesia in elective caesarean section. But hypotension following spinal anaesthesia is a common and dreadful complication. Use of non-pharmacological methods are not found to be effective, hence use of vasopressor is indicated in management of hypotension. Among vasopressors norepinephrine is a drug which manages hypotension as well as maintains the hemodynamic parameters of the parturient.

Here in our study we would find out the optimal dosage of norepinephrine bolus for management of spinal hypotension by recording the incidence of successful treatment of hypotension which is considered when systolic blood pressure increases by 20 percent  within 2 minutes of the administration of different regimens of norepinephrine bolus. We will also try to find which regimen provides better hemodynamic stability and fetal outcome with least adverse reactions.

A total of 150 parturient  aged 18 to 45 years belonging to American society of Anaesthesiologists ASA I and II undergoing lower segment caesarean section under spinal anaesthesia will be divided into three groups of Group A Group B and Group C by block randomization. Group A patients will receive norepinephrine 5 microgram as intravenous bolus  group B patients will receive norepinephrine 8 microgram as intravenous bolus  group C patients will receive norepinephrine 10 microgram  as intravenous bolus whenever the systolic blood pressure fall below 20 percent from the baseline. The incidence of successful treatment of hypotension in each group will be noted. The number of occurrences of hypotension before delivery and after delivery  will be also be recorded. Hemodynamic parameters will be monitored and recorded. The baseline values will be compared with the values obtained after spinal block in all the three groups. The incidence of bradycardia hypertension and foetal outcome such as Apgar score and umbilical vein blood gases will also be recorded.

The findings and observations made during the entire study will be tabulated  graphically depicted whenever possible statistically analysed and inference will be drawn.

 
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