| CTRI Number |
CTRI/2023/01/049041 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
09/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparison of blood pressure and heart rate changes following spinal anaesthesia for below umbilicus surgery between people on treatment for blood pressure control with people who have normal blood pressure . |
|
Scientific Title of Study
|
A Comparison Of
Haemodynamic Response Following Subarachnoid Block Between Controlled Hypertensive
And Normotensive Patients Undergoing Below Umbilicus Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Baby kumari |
| Designation |
Post graduate student |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College
New Delhi
DELHI
110029
India |
| Phone |
7060192539 |
| Fax |
|
| Email |
babykumari8730@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhu dayal |
| Designation |
Professor |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College
New Delhi
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhu dayal |
| Designation |
Professor |
| Affiliation |
Safdarjung hospital and Vardhman Mahavir Medical College New Delhi |
| Address |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College
New Delhi
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College |
|
|
Primary Sponsor
|
| Name |
Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care Ground floor main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College New Delhi 110029 Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vardhman Mahavir Medical College |
Department of Anaesthesia and Intensive care Ground floor main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College New Delhi 110029 Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Baby kumari |
VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
Department of Anaesthesia and Intensive care.Ground floor,main operation theatre building.Safdarjung hospital and Vardhman Mahavir Medical College,New Delhi 110029
New Delhi
DELHI |
7060192539
babykumari8730@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for elective surgeries for lower abdomen, lower limbs, urological and perineum under spinal anesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients with other coexisting diseases like valvular cardiac diseases, severe hypovolemia, sepsis and coagulopathy.
2. Pregnancy.
3. Patients with known allergy to local anesthetic
4. Contraindications to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare incidence of hypotension in controlled hypertensive and normotensive patients undergoing below umbilicus surgery during Subarachnoid block by monitoring systolic and diastolic blood pressure, mean arterial pressure intra operatively |
Intra operative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. : Compare haemodynamic parameters by monitoring heart rate and SpO2.
Evaluate the amount intra operatively. of IV fluid and dose of inj.Mephentermine required to correct hypotension Evaluate the incidence of bradycardia with hypotension and use of inj. Atropine.
To Compare of 2 spinal segment regression time in normotensive and controlled hype patients. |
Intra operative |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
20/01/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is competitive cross sectional observational study. The aim is to compare Haemodynamic Response Following Subarachnoid Block Between Controlled Hypertensive And Normotensive Patients Undergoing Below Umbilicus Surgery. Primary objective is to compare incidence of hypotension in controlled hypertensive and normotensive patients undergoing below umbilicus surgery during Subarachnoid block by monitoring systolic and diastolic blood pressure, mean arterial pressure intra operatively. Secondary objective is Compare haemodynamic parameters by monitoring heart rate and SpO2 also Evaluate the amount of IV fluid and dose of inj.Mephentermine required to correct hypotension intra operatively and Evaluate the incidence of bradycardia with hypotension and use of inj. Atropine. We also Compare of 2 spinal segment regression time in normotensive and controlled hypertensive patients. Total sample size taken is 160 (80 patients per group) |