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CTRI Number  CTRI/2024/08/071767 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 01/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the comparison of prophylactic norepinephrine and phenylephrine intravenous infusion for the treatment of post spinal anaesthesia induced hypotension in elderly patients 
Scientific Title of Study   Comparison of prophylactic equipotent norepinephrine and phenylephrine infusion for the treatment of post spinal anaesthesia induced hypotension - a prospective double blinded randomized controlled 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  Chatakondu Sneha 
Designation  MBBS, Post Graduation (MD) Anaesthesiology and Critical care 
Affiliation  Sri Venkateswara Institute of Medical Sciences, Tirupati 
Address  Department of Anaesthesiology , SVIMS, Alipiri, Tirupati, Chittoor district, Andhra Pradesh, 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9440659659  
Fax    
Email  sneha.chatakondu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aloka Samantaray 
Designation  Professor and HOD,Department of Anaesthesiology and critical care medicine, SVIMS 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology, SVIMS, Alipiri, Tirupati, Chittoor, Andhra pradesh, 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aloka Samantaray 
Designation  Professor and HOD,Department of Anaesthesiology and critical care medicine, SVIMS 
Affiliation  Sri Venkateswara Institute of Medical Sciences 
Address  Department of Anaesthesiology, SVIMS, Alipiri, Tirupati, Chittoor, Andhra pradesh, 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara Institute of Medical Sciences (SVIMS), Alipiri Road, Tirupati, Chittoor, Andhra Pradesh, 517507  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Aloka Samantaray  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiology, Svims, Alipiri road, Tirupati, Chittoor,517507
Chittoor
ANDHRA PRADESH 
9493547653

aloksvims@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Sri Venkateswara Institute of Medical Sciences   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  Norepinephrine  9 micrograms per ml per minute over 45 minutes as infusion started after 1 minute following spinal anaesthesia 
Comparator Agent  Phenylephrine  100 micrograms per ml per minute over 45 minutes as infusion started after 1 minute following spinal anaesthesia  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  (1) Elderly patients (more than 50 years) who are scheduled for surgery under spinal anaesthesia
(2) Patients of American society of anaesthesiologists I,II,III
 
 
ExclusionCriteria 
Details  Contraindication of spinal anaesthesia.
History of allergy to any of the study drugs.
Patients with cardiac morbidities.
Hypertensive patients.
Patients with advanced comorbidity like hyperthyroidism and autonomic neuropathy.
Patients on heart rate regulating drugs. 
 
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 
Incidence of spinal anaesthesia induced hypotension where mean arterial pressure is less than 80% of the baseline reading for 45 minutes and not related to blood loss  At baseline, each minute for the first 10 minutes, every 3rd minute for the next 35 minutes after induction of spinal anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
1.Mean heart rate beats per minute
2.The proportion of patients having bradycardia with heart rate less than 50 beats per minute.
3.Incidence of reactive hypertension increased mean arterial pressure with more than 25% of the baseline reading.
4.The proportion of patients requiring rescue boluses of ephedrine.
5.Any other adverse events. 
1. From 2 minutes to 45 minutes after induction of spinal anaesthesia.
2. From 1 minute to 45 minutes after induction of spinal anaesthesia.
3. From 1 minute to 45 minutes after induction of spinal anaesthesia.
4.From 1 minute to 45 minutes after induction of spinal anaesthesia.
5. Within 24 hours 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
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/ Phase 4 
Date of First Enrollment (India)   12/08/2024 
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="0"
Months="3"
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 following spinal anaesthesia is most commonly encountered event. Vasopressors are the most preferred drugs to treat and prevent hypotension due to spinal anaesthesia. Currently both norepinephrine and phenylephrine are the favored vasopressor to counteract spinal anaesthesia induced hypotension in obstetric population. There are not many studies comparing the effect of equipotent dose of norepinephrine and phenylephrine in treating spinal anaesthesia among elderly population. In this study we aim to compare the changes in heart rate and blood pressure following prophylactic intravenous infusions of norepinephrine or phenylephrine in elderly patients under elective surgery under spinal anaesthesia. We will recruit elderly patients above 50 years of age considering all the inclusion and exclusion criteria. In this randomized double blind study, we will obtain informed consent from the patient and after administration of spinal anaesthesia we start infusion of either norepinephrine or phenylephrine after one minute in our sample of patients and will monitor for incidence of hypotension, bradycardia, reactive hypertension and other adverse events for 45 minutes following the spinal anaesthesia procedure. Postoperatively we will monitor the patient in recovery room the next 24 hours for any adverse events. We will note the entire collected data onto study proforma and uploaded onto excel sheet. Statistical analysis will be done.

 
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