| CTRI Number |
CTRI/2018/04/013515 [Registered on: 27/04/2018] Trial Registered Prospectively |
| Last Modified On: |
10/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Reliability of ultrasound examination for the prediction of fall in blood pressure under anesthesia in patients undergoing neuro-surgery†|
|
Scientific Title of Study
|
Reliability of pre-induction inferior vena cava assessment with ultrasound for the prediction of post-induction hypotension in neurosurgical patients undergoing intracranial surgery†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit goyal |
| Designation |
Academic resident |
| Affiliation |
National institute of mental health and neuro sciences |
| Address |
Department of neuroanesthesia,
NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8800801784 |
| Fax |
|
| Email |
amitgoyal26@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Bhadrinarayan |
| Designation |
professor |
| Affiliation |
National institute of mental health and neuro sciences |
| Address |
Department of neuroanesthesia,
NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9480829711 |
| Fax |
|
| Email |
n_bhadri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Amit goyal |
| Designation |
Academic resident |
| Affiliation |
National institute of mental health and neuro sciences |
| Address |
Department of neuroanesthesia,
NIMHANS, Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8800801784 |
| Fax |
|
| Email |
amitgoyal26@ymail.com |
|
|
Source of Monetary or Material Support
|
| National institute of mental health and neuro sciences
Hosur Road, Bangalore-560029, karnataka, india |
|
|
Primary Sponsor
|
| Name |
National institute of mental health and neuro sciences |
| Address |
Hosur road
Bangalore-560029
Karnataka
India |
| Type of Sponsor |
Government 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 |
| Amit goyal |
National institute of mental health and neuro sciences |
OT complex, division of neuroanesthesia, Department of neuroanestthesia and critical care.
Bangalore
KARNATAKA |
8800801784
amitgoyal26@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Neurosurgical patients., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
2. ASA status I to III
3. Patients undergoing intracranial neurosurgical procedures
|
|
| ExclusionCriteria |
| Details |
1. Age group below 18 and above 65 years
2. ASA status IV and above
3. Patients with traumatic brain injury
4. Patients on mechanical ventilation and/ not having spontaneous breathing
5. Multiple intubation attempt or prolonged intubation time
6. Difficult airway
7. Baseline mean blood pressure (MAP) <65mmHg
8. Repeat surgery within a week
9. Patient with significant cardiac impairment
10. Skin infection at the site of examination
11. History of recent upper abdominal surgery
12. Autonomic nervous disorders
13. Prior use of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish a relationship between pre-induction IVC diameter maximum (IVCDmax), Collapsibility index (CI) and post-induction reduction in mean arterial blood pressure (MAP) in neurosurgical patients. |
0,1,3,5,10 MINUTES |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To observe the duration and severity of reduction in mean arterial blood pressure following induction of anesthesia, in relation to the IVCDmax and CI.
2. To calculate the total dose of mephentermine required to correct hypotension following induction of anesthesia, in relation to the IVCDmax and CI.
|
0,1,3,5,10 MINUTES |
|
|
Target Sample Size
|
Total Sample Size="156"
Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/05/2018 |
| Date of Study Completion (India) |
31/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Hypotension
is one of the most common complications during general anesthesia,
specially after induction of general anesthesia. Its
occurrence is affected by several factors, mainly hypovolemia, old age, ASA
status 3 and above, anesthetic drugs and dosage, impaired
compensatory mechanisms and impaired cardiac function. Patients with
intracranial pathological conditions are more vulnerable to hypovolemia,
resulting from poor oral intake (low GCS, lower cranial nerve palsies),
vomiting, effect of anti-edema drugs (example- mannitol) and complications like
diabetes insipidus, which may lead to post induction
hypotension. The neuroanesthesiologist plays a key role in management of
hypotension, by preemptively diagnosing and correcting the hypovolemic status,
and thereby reduce the incidence of post-induction hypotension. However, an
association between preoperative volume status and the severity of
post-induction hypotension has not been established in neurosurgical patients. The aim of this study is to assess the correlation between ultrasonographic measurement
of inferior vena cava diameter and post-induction hypotension during general
anesthesia in neurosurgical patients.
|