| 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
|
|
|
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
|
|
|
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. |