| 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
|
|
|
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
|
|
|
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. |