| CTRI Number |
CTRI/2018/05/013682 [Registered on: 04/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
11/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To know the dosage of drug(propofol)needed to anaesthetise a patient with head injury coming for surgery with help of a monitor called bilateral BIS ( bispectral index).
|
|
Scientific Title of Study
|
To evaluate the dose requirement of propofol for induction of anaesthesia in patients with traumatic brain injury using bilateral Bispectral Index |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Seham Syeda |
| Designation |
Senior Resident, Academics |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical Care,
NIMHANS.
Bangalore
KARNATAKA
560029
India |
| Phone |
9886094357 |
| Fax |
|
| Email |
sehamsyeda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Bhadrinarayan |
| Designation |
Professor |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical Care,
NIMHANS.
Bangalore
KARNATAKA
560029
India |
| Phone |
9448084257 |
| Fax |
|
| Email |
n_bhadri@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seham Syeda |
| Designation |
Senior Resident, Academics |
| Affiliation |
National Institute of Mental Health And Neurosciences |
| Address |
Department of Neuroanaesthesia and Neurocritical Care,
NIMHANS.
Bangalore
KARNATAKA
560029
India |
| Phone |
9886094357 |
| Fax |
|
| Email |
sehamsyeda@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health And Neurosciences |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health And Neurosciences |
| Address |
NIMHANS,
Hosur road,
Bangalore-560029 |
| 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 Seham Syeda |
National Institute of Mental Health And neurosciences |
Emergency OT/ trauma OT
National Institute of Mental Health and Neurosciences.
Hosur road
Bangalore - 560029
Bangalore
KARNATAKA |
9886094357
sehamsyeda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| National Institute of Mental Health And Neurosciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Patients with traumatic brain injury coming for surgery, (1) ICD-10 Condition: S065||Traumatic subdural hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex, aged between 18- 60 years with mild, moderate and severe traumatic brain injury (TBI) presenting for surgery within 48 hours of trauma . |
|
| ExclusionCriteria |
| Details |
Patients who are hemodynamically unstable, patients with relative refusing to give consent, patients in whom BIS recording is not possible, patients with anticipated difficult airway, patients history of severe cardiac, pulmonary, liver or renal disease, or obesity (body mass index >30) and pregnancy. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the dose requirement of propofol for induction of anaesthesia in patients with TBI undergoing surgery using bilateral BIS. |
At the end of induction , when BIS value decreases to less than or equal to 40 on the uninjured side. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the baseline BIS on the injured and non-injured side in all patients of TBI undergoing surgery
2. To determine the difference in propofol requirement in male and female patients with TBI.
3. To determine the difference between preoperative and postoperative BIS
4.The difference between preoperative and postoperative BIS and its correlation with short term outcome (GOSE).
|
1.At the beginning of induction.
2. At the end of the anaesthetic induction.
3. At the end of the surgical procedure.
4.At the end of 30 days from recruitment |
|
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Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/04/2017 |
| Date of Study Completion (India) |
11/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="13" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Previous studies have demonstrated a decreased requirement of propofol in patients undergoing neurosurgical procedures as compared to non-neurological procedures. However, there is a paucity of literature with regard to the anaesthetic requirements in patients with TBI
We conducted this study to determine the dose requirement of propofol for induction of anaesthesia in patients with TBI undergoing surgery, using a bilateral BIS monitor.
Methodology: 90 patients of either sex with mild , moderate and severe head injury coming for surgery within 48 hrs of trauma will be enrolled in this study. Dose requirement of propofol in order to reduce the value of BIS to less than or equal to 40 on the uninjured side using Schnider module on target controlled infusion (TCI) pump will be determined in each group of patient. |