| CTRI Number |
CTRI/2023/04/051451 [Registered on: 10/04/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing the effect of Ephedrine and Phenylephrine infusion on hemodynamic stability after Spinal Anaesthesia in elderly patients |
|
Scientific Title of Study
|
A Comparative study of infusion of Ephedrine and Phenylephrine on hemodynamic stability after Spinal Anaesthesia in elderly patients undergoing lower limb Orthopaedic Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Sufian Ibrahim |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
8722564874 |
| Fax |
|
| Email |
syedsufiyaan.95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Basavaraj Patil |
| Designation |
Associate Professor |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
7829655342 |
| Fax |
|
| Email |
drbnp2000@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Sufian Ibrahim |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College |
| Address |
Department of Anaesthesiology
Shri B M Patil Medical College
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Bijapur
KARNATAKA
586103
India |
| Phone |
8722564874 |
| Fax |
|
| Email |
syedsufiyaan.95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Karnataka
pin 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College |
| Address |
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Pin 586103
Karnataka |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Syed Sufian Ibrahim |
Shri B M Patil Medical College |
Department of Anaesthesiology
Bangaramma Sajjan Campus
BLDE University
Vijayapura
Bijapur
KARNATAKA |
8722564874
syedsufiyaan.95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri B M Patil Medical College |
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 |
| Intervention |
Injection EPHEDRINE |
Alpha and Beta Adrenergic agonist which increases Cardiac output and prevents decrease in Heart rate
Route: Intravenous Injection
Dosage: 30mg
Frequency: Infusion for 30 minutes |
| Comparator Agent |
Injection MEPHENTERMINE |
Alpha Adrenergic agonist used to maintain Blood Pressure in Hypotension
Route: Intravenous Injection
Dosage: 6mg
Frequency: Infusion for 30 minutes |
| Intervention |
Injection PHENYLEPHRINE |
Alpha Adrenergic agonist causes Reflex Bradycardia
Route: Intravenous Injection
Dosage: 250 mcg
Frequency: Infusion for 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age above 60 years
Patients undergoing lower limb orthopaedic surgeries |
|
| ExclusionCriteria |
| Details |
Infection at the site of injection
Uncontrolled hypovolemia
Allergy or Hypersensitivity to Vasoconstrictors
Increased intracranial pressure
Coagulopathy,sepsis,fixed cardiac output states,neurological disease
Uncontrolled Hypertension,Diabetes Mellitus and Heart failure
Phaeochromocytoma
Hypothyroidism
MAO inhibitors,Tricyclic Antidepressants
Phenothiazine compounds
Recent MI and CABG |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Ephedrine and Phenylephrine on hemodynamic stability after spinal anaesthesia |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the number of rescue doses of Ephedrine and Phenylephrine given after spinal anaesthesia |
30 minutes |
|
|
Target Sample Size
|
Total Sample Size="174"
Sample Size from India="174"
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)
|
10/04/2023 |
| 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="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is a Prospective Randomized, Parallel group study. This study consists of 3 groups where Group E who will receive Injection EPHEDRINE 30mg infusion for 30 minutes, Group P who will receive Injection PHENYLEPHRINE 250mcg infusion for 30 minutes and Control group will receive intravenous bolus injection mephentermine 6mg when required .174 patients posted for lower limb orthopedic surgeries under Spinal Anesthesia will be equally divided into 3 groups as 58 each. The study will be conducted in Shri. BM Patil Medical College Hospital and Research Centre Vijayapura, Karnataka. The primary outcome is to compare the effect of Ephedrine and Phenylephrine on hemodynamic stability after Spinal Anesthesia and secondary outcome is to compare the number of rescue doses of Ephedrine and Phenylephrine given after Spinal Anesthesia. |