| CTRI Number |
CTRI/2024/04/066310 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
blood pressure monitoring -invasive and non invasive methods during induction of general anesthesia in neurosurgical patients-an observational study |
|
Scientific Title of Study
|
Continuous Intra-arterial Versus intermittent oscillometric blood pressure monitoring during induction of general anesthesia in neurosurgical patients-an observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharmila Devadoss |
| Designation |
PG Student |
| Affiliation |
Army Hospital R and R |
| Address |
2nd floor
Department of Anaesthesiology and critical care
Army Hospital Rand R
New Delhi 110057
India
New Delhi
DELHI
110057
India |
| Phone |
7010942774 |
| Fax |
|
| Email |
drsharmiladoss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavna Hooda |
| Designation |
MBBS MD DM Neuroanesthetist |
| Affiliation |
Army Hospital RandR |
| Address |
Army Hospital R&R Department of Anaesthesiology and critical care
Army Hospital Rand R New Delhi 110057 India
New Delhi
DELHI
110057
India |
| Phone |
9910663810 |
| Fax |
|
| Email |
bhavnahooda2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharmila Devadoss |
| Designation |
PG Student |
| Affiliation |
Army Hospital R and R |
| Address |
2nd floor Department of Anaesthesiology and critical care
Army Hospital Rand R New Delhi 110057 India
New Delhi
DELHI
110057
India |
| Phone |
9790768177 |
| Fax |
|
| Email |
drsharmiladoss@gmail.com |
|
|
Source of Monetary or Material Support
|
| 2nd floor ,Department of Anesthesiology and critical care,Army Hospital R and R, Delhi Cantt |
|
|
Primary Sponsor
|
| Name |
Army Hospital Rand R |
| Address |
Army Hospital R and R Department of Anaesthesiology and critical care
Army Hospital Rand R New Delhi 110057 India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sharmila Devadoss |
Army Hospital R& R |
2nd floor Department of Anaesthesiology and critical care
Army Hospital Rand R New Delhi 110057 India
New Delhi
DELHI |
7010942774
drsharmiladoss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Army Hospital R and R |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Elective neurosurgery patients with General anesthesia in whom continuous intra arterial blood pressure monitoring was planned for clinical indications
ASA I and II |
|
| ExclusionCriteria |
| Details |
Emergency surgery ASA III IV V VI patient who require femoral artery catheterization patient who are not in sinus rhythm |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Early detection of hypotension during induction of general anesthesia in neurosurgical patients |
Hypotension MAP under 65 in first 15 mins of induction of anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a)Area underMAP of 60 ,50 & 40mmHgb)duration of MAP under 60,50 & 40mmHgc) Vasopressor use |
IBP reading 10seconds for 2mins followed by 30 seconds for 3 mins followed by each minute & NIBP reading every one minute |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
01/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/06/2025 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Study is about early detection of hypotension during induction of general anesthesia in neurosurgical patients by placing an Intra arterial line under local anesthesia , prior to induction of anesthesia in patients in whom arterial line is placed for clinical indications and compare with NIBP reading |