| CTRI Number |
CTRI/2023/08/056993 [Registered on: 28/08/2023] Trial Registered Prospectively |
| Last Modified On: |
24/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparison of two drugs norepinephrine and phenylephrine to prevent hypotension after spinal anaesthesia in patients above 60 years posted for hip and femur surgery |
|
Scientific Title of Study
|
INFUSION OF NOREPINEPHRINE VERSUS PHENYLEPHRINE FOR PREVENTION OF SUBARACHNOID BLOCK INDUCED HYPOTENSION IN ELDERLY PATIENTS UNDERGOING HIP AND FEMUR SURGERIES |
| Trial Acronym |
Comparison of vasopressor agents norepinephrine and phenylephrine for prevention of subarachnoid block induced hypotension in elderly patients posted for hip and femur surgery
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NEERU LUTHRA |
| Designation |
Professor , Anaesthesia , DMCH |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9815500960 |
| Fax |
|
| Email |
drneeru1977@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubham Longia |
| Designation |
PG Resident, Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9872896482 |
| Fax |
|
| Email |
shubhamlongia30@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubham Longia |
| Designation |
PG Resident, Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia, Dayanand Medical College and Hospital, Civil Lines , Ludhiana Punjab India
Ludhiana
PUNJAB
141001
India |
| Phone |
9872896482 |
| Fax |
|
| Email |
shubhamlongia30@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital , Tagore Nagar , Civil Lines, Ludhiana 141001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar , Civil Lines, Ludhiana 141001 Punjab India |
| 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 |
| Dr Neeru Luthra |
Dayanand Medical College and Hospital |
Department of Anaesthesiology , Tagore Nagar , Civil Lines, Ludhiana 141001 Punjab India
Ludhiana
PUNJAB |
9815500960
drneeru1977@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee Dayanand Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I952||Hypotension due to drugs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Norepinephrine for prevention of subarachnoid block induced hypotension |
Patients in group NE will be given intravenous infusion of norepinephrine.Norepinephrine 8 micrograms/ml ( prepared by diluting 4 mg NE in 500 ml saline ) will be started at 60ml/hour and tapered according to study protocol. |
| Comparator Agent |
Phenylephrine for prevention of subarachnoid block induced hypotension |
Patients in group PE will be given intravenous infusion of Phenylephrine.phenylephrine 100 micrograms/ml ( prepared by diluting 10 mg of PE in 100 ml saline) at 60 ml/hour and tapered according to study protocol |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elderly patients above 60 years of age posted for hip and femur surgeries |
|
| ExclusionCriteria |
| Details |
1. Patients with history of allergy to any of the study drugs
2. Patients with contraindications of spinal anaesthesia
3. Patient refusal |
|
|
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 |
Episodes of hypotension (defined as Systolic blood pressure less than 80% of baseline or an absolute value of less than 100 mmHg).
|
Upto 45 minutes after sub arachnoid block
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total amount of Phenylephrine or Norepinephrine
|
Upto 45 minutes after sub arachnoid block |
| Episodes of Bradycardia |
Upto 45 minutes after sub arachnoid block |
| Incidence of hypertension |
Upto 45 minutes after sub arachnoid block |
|
|
Target Sample Size
|
Total Sample Size="134"
Sample Size from India="134"
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)
|
07/09/2023 |
| 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="3"
Days="3" |
|
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
|
Spinal anaesthesia is frequently used for lower extremity surgeries.Sympathetic blockade after spinal anaesthesia results in venodilation which reduces venous return and hence cardiac output and results in hypotension . Therefore, prophylactic use of alpha-adrenergic agonist drugs is recommended which act by inducing constriction of compliant veins , effectively reversing the vasodilatory effects of spinal anaesthesia. A prospective , interventional , double blinded , randomised study will be conducted on elderly more than 60 years old patients posted for hip and femur surgeries under sub arachnoid block. In this study we aim to compare the effect of using prophylactic Norepinephrine versus Phenylephrine infusion for prevention of spinal induced hypotension in elderly population undergoing hip and femur surgeries. A randomized controlled trial will be conducted on 134 elderly patients ( > 60 years of age ) undergoing hip and femur surgeries under spinal anaesthesia. An arterial line will be secured using a 20 G arterial cannula in the radial artery. The patients will be divided into two groups: Norepinephrine (NE) and Phenylephrine (PE) -67 each -depending on the drug administered which will be started before giving sub arachnoid block to the patient . All patients will be administered 2.2 ml volume of bupivacaine 0.5% (1.7 ml) with 25 micrograms (0.5 ml) of fentanyl to achieve subarachnoid block Monitoring of invasive arterial blood pressure will be done for first 45 minutes of surgery and readings will be noted every 2 minutes
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