| CTRI Number |
CTRI/2024/03/064300 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Heart rate and blood pressure changes in Hypertensive and Normotensive Patients Undergoing spinal anaesthesia for below Umbilicus surgery. |
|
Scientific Title of Study
|
Comparison of Hemodynamic Response in Hypertensive and Normotensive Patients Undergoing spinal anaesthesia for below Umbilicus surgery.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramya DV |
| Designation |
Assistant professor , Department of Anaesthesia |
| Affiliation |
MVJ medical collage and research hospital |
| Address |
MVJ medical collage and research hospital, hoskote
MVJ medical College and research hospital, Dandupalya,hoskote
Bangalore
KARNATAKA
562114
India |
| Phone |
9591889505 |
| Fax |
|
| Email |
ramyavenkatesh1359@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramya DV |
| Designation |
Assistant professor , Department of Anaesthesia |
| Affiliation |
MVJ medical collage and research hospital |
| Address |
MVJ medical collage and research hospital, hoskote
MVJ medical collage and research hospital, Dandupalya, hoskote
KARNATAKA
562114
India |
| Phone |
9591889505 |
| Fax |
|
| Email |
ramyavenkatesh1359@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya DV |
| Designation |
Assistant professor , Department of Anaesthesia |
| Affiliation |
MVJ medical collage and research hospital |
| Address |
MVJ medical collage and research hospital, Dandupalya hoskote
MVJ medical collage and research hospital, Dandupalya, hoskote
KARNATAKA
562114
India |
| Phone |
9591889505 |
| Fax |
|
| Email |
ramyavenkatesh1359@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Ramya Dv, Assistant professor, Department of Anaesthesia,MVJ medical collage and research hospital, Dandupalya, hoskote 562114 |
|
|
Primary Sponsor
|
| Name |
Dr Ramya DV |
| Address |
MVJ medical collage and research hospital, Dandupalya, hoskote |
| 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 Ramya DV |
MVJ medical collage and research hospital |
Department of Anaesthesia,MVJ medical collage and research hospital, Dandupalya, hoskote
Bangalore
KARNATAKA |
9591889505
ramyavenkatesh1359@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MVJMC and RH |
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 |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients, male and female
age limit 40-60yrs
|
|
| ExclusionCriteria |
| Details |
ASA 3, patients contraindicated to spinal anaesthesia
pregnant women
degranged coagulation |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate, blood pressure changes |
Baseline pre operative vitals, after preloading,after spinal 1,3,5,10,20,30,40,50,60 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Same as primary outcome, heart rate & blood pressure changes |
Baseline pre operative vitals, after preloading,after spinal at 1,3,5,10,20,30,40,50,60 mins |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/03/2024 |
| Date of Study Completion (India) |
10/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
10/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
Most common hemodynamic instability following spinal anaesthesia is hypotension and bradycardia The current practice to treat hypotension is systolic BP of less than 90 mmHg or a decrease of greater than 25–30% from baseline. The primary outcome of the present study is to determine the percentage change in blood pressure and heart rate after spinal anesthesia among hypertension and normotensive patients who is undergoing surgery under spinal anaesthesia in this institution.
|