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CTRI Number  CTRI/2024/03/064165 [Registered on: 14/03/2024] Trial Registered Prospectively
Last Modified On: 15/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing prophylactic noradrenaline infusion and phenylephrine infusion after preloading with iv fluids for prevention of fall in blood pressure in elderly patients undergoing proximal femoral nailinig under spinal anaesthesia. 
Scientific Title of Study   A randomised double blinded study comparing prophylactic noradrenaline infusion and phenylephrine infusion after preloading with crystalloid for prevention of hypotension in geriatric patients undergoing proximal femoral nailinig under spinal anaesthesia. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tharigonda Balaji 
Designation  Assistant professor 
Affiliation  Government Medical College,Kadapa 
Address  Department of Anesthesiology, Government Medical College, Kadapa

Cuddapah
ANDHRA PRADESH
516002
India 
Phone  9491152692  
Fax    
Email  meetdrbalaji@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Tharigonda Balaji 
Designation  Assistant professor 
Affiliation  Government Medical College,Kadapa 
Address  Department of Anesthesiology, Government Medical College, Kadapa

Cuddapah
ANDHRA PRADESH
516002
India 
Phone  9491152692  
Fax    
Email  meetdrbalaji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tharigonda Balaji 
Designation  Assistant professor 
Affiliation  Government Medical College,Kadapa 
Address  Department of Anesthesiology, Government Medical College, Kadapa

Cuddapah
ANDHRA PRADESH
516002
India 
Phone  9491152692  
Fax    
Email  meetdrbalaji@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anesthesia Government Medical College Kadapa 
 
Primary Sponsor  
Name  Dr Tharigonda Balaji 
Address  Assistant Professor Department of Anesthesiology Government Medical College Kadapa 
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 Tharigonda Balaji  Government General Hospital  Department of anesthesia Government Medical College Kadapa
Cuddapah
ANDHRA PRADESH 
9491152692

meetdrbalaji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe, Government Medical College, Kadapa  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 
Comparator Agent  Prophylactic infusion of norepinephrine for prevention of hypotension  Patients in group B will receive norepinephrine infusion at a rate of 0.05mcg/kg/min 
Intervention  Prophylactic infusion of phenylephrine for prevention of hypotension   patient in group A receive phenylephrine infusion at rate of 0.5mcg/kg/min 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1.ASA 2 & 3
2.Aged between 65 – 80 yrs.
3.Patients posted for PFN surgeries. 
 
ExclusionCriteria 
Details  1.Patients with known cardiac abnormalities.
2.Uncontrolled hypertension.
3.Hyperthyroid patients.
4.Coagulation or renal disorders.
5.Infection at the site of spinal anaesthesia 
 
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 
Prevention Of Spinal Hypotension  heart rate and mean arterial blood pressure at Baseline, every 5 min for first half an hour, every 10 min for next 90 min 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events such as bradycardia, nausea and vomiting will be recorded  intra operative period and 6 hrs post operatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   28/03/2024 
Date of Study Completion (India) 14/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Aim of this study is to compare effectiveness of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension.The primary objective of this study is  to compare the effect of prophylactic norepinephrine infusion and phenylephrine infusion after preloading with crystalloid in preventing hypotension in geriatric patients undergoing proximal femoral nailing surgeries under spinal anaesthesia. Secondary objectives are to assess the incidence of adverse events between the two groups. Total number of 60 patients between the age group of 65-80years, belonging to ASA physical status ii/iii, posted for proximal femoral  nailing surgeries under spinal anaesthesia will be recruited and randomly assigned into two equal groups using computer generated random list. All patients will be preloaded with crystalloids 10ml/kg. After preloading the patients with crystalloids 10ml/kg, subarachnoid block will be achieved with intrathecal 0.5% bupivacaine heavy 2.5ml combined with 25 mics fentanyl. Immediately following subarachnoid block, patients in Group A (n-30) will  receive inj.phenylephrine infusion at rate of  0.5mcg/kg/min and patients in Group B (n-30) will receive  inj.norepinephrine infusion at rate of 0.05 mcg/kg/min. Haemodynamic parameters including mean arterial pressure (MAP) and heart rate (HR) will be assessed. Adverse events such as bradycardia, nausea and vomiting  will  also be recorded. Data will be analysed with chi- square test and student-t test.

 

 
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