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CTRI Number  CTRI/2023/08/056943 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 24/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Norepinephrine infusion for controlling spinal anaesthesia induced hypotension in caesarian section. 
Scientific Title of Study   Effect of different doses of norepinephrine infusion for controlling spinal anaesthesia induced hypotension in caesarean section- a randomized controlled study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANISH M 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences , Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  8547116936  
Fax    
Email  anishmohan07193@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr T Hemjit Singh 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences , Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  9436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr T Hemjit Singh 
Designation  Assistant Professor 
Affiliation  Regional Institute of Medical Sciences , Imphal 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  9436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Regional Institute of Medical Sciences, Imphal, Manipur 
 
Primary Sponsor  
Name  Anish M 
Address  Regional Institute of Medical Sciences, Imphal, Manipur 
Type of Sponsor  Other [Self] 
 
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 Anish M  Regional Institute of Medical Sciences  Operation Theatre complex (OT 1-8),Department of Anaesthesiology, Regional Institute of Medical Sciences
Imphal West
MANIPUR 
8547116936

anishmohan07193@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board,Regional Institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 1||Obstetrics,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1 ml/kg/hr of Normal saline  Study participants will be randomized into 4 groups. Comparator group recieving 1 ml/kg/hr of intravenous Normal saline infusion after giving spinal anaesthesia till the completion of surgery 
Intervention  Administration of intravenous infusion of 5 micrograms/kg/hr or 8 micrograms/kg/hr or10 micrograms/kg/hr of Norepinephrine   Study participants will be randomized into 4 groups. Intervention groups recieving either intravenous infusion of 5 micrograms/kg/hr or 8 micrograms/kg/hr or10 micrograms/kg/hr of norepinephrine after giving spinal anaesthesia till the completion of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Patients of age group 18 to 50 years undergoing elective caesarean section
2.Patients with ASA physical grade I or II



 
 
ExclusionCriteria 
Details  1. History of allergy to local anaesthetic agent and/ or study drugs

2. Bleeding disorders like Von Willebrand disease, ITP, platelet count <50.000/microlitre, prothrombin time> 14 seconds, International normalised ratio (INR) > 1.5

3. Local site infection

4. Spinal deformity

5. Cardiac, respiratory diseases and kidney disorder, neurological deficit

6. Parturients with PET or any hypertensive disorder.

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Occurrence of hypotension  Outcome will be continuously recorded every 2 mins till 10 mins then every 5 mins until the end of surgery & data will be asessed at the end of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Apgar score, umbilical vein blood gases record ,
Hemodynamic changes, norepinephrine consumption, adverse effects

 
All outcomes will be continuously recorded every 2 mins till 10 mins & then every 5 mins until the end of surgery 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   04/09/2023 
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 Yet Recruiting 
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  

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 infusion for management of spinal hypotension by recording the incidence of hypotension after different regimens of norepinephrine infusion. We will also try to find which regimen provides better hemodynamic stability and fetal outcome with least adverse reactions.

A total of 120 parturient, aged 18 to 50 years belonging to American society of Anaesthesiologists (ASA) I and II, undergoing lower segment caesarean section under spinal  anaesthesia will be divided into four groups (Group A, Group B, Group C and Group D) by block randomization. Group A patients will receive norepinephrine 5 μg/kg/h as intravenous infusion,  group B patients will receive norepinephrine 8 μg/kg/h as intravenous infusion, group C patients will receive norepinephrine 10 μg/kg/h as intravenous infusion and group D will receive normal saline as intravenous infusion after sub arachnoid block at the rate of 1ml/kg/hr. The number of occurence of hypotension (before delivery and after delivery) will be noted. Hemodynamic parameters will be monitored and recorded. The baseline values will be compared with the values obtained after spinal block in all the four 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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