| CTRI Number |
CTRI/2022/09/045560 [Registered on: 15/09/2022] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of two different anesthetic agents (Propofol and Sevoflurane) on the blood flow and oxygen concentration in the brain with patients lying face down |
|
Scientific Title of Study
|
Assessment of cerebral blood flow and oxygenation during Propofol versus Sevoflurane based anaesthesia in prone position |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Geetha L |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospital |
| Address |
Ramaiah Medical College
M S Ramaiah nagar
Mathikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
geetha4kiran@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha L |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospital |
| Address |
Ramaiah Medical College
M S Ramaiah nagar
Mathikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
geetha4kiran@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha L |
| Designation |
Associate Professor |
| Affiliation |
Ramaiah Medical College and Hospital |
| Address |
Ramaiah Medical College
M S Ramaiah nagar
Mathikere
Bangalore
KARNATAKA
560054
India |
| Phone |
|
| Fax |
|
| Email |
geetha4kiran@yahoo.in |
|
Source of Monetary or Material Support
Modification(s)
|
| RAMAIAH MEDICAL COLLEGE, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 |
|
|
Primary Sponsor
|
| Name |
DR GEETHA L |
| Address |
M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 |
| Type of Sponsor |
Other [INDIVIDUAL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR JAYA HASITA |
M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr GEETHA L |
RAMAIAH MEDICAL COLLEGE |
Department of Neuroanesthesiology, Neurosciences Block, Ramaiah Memorial Hospital
M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA |
9611897899
geetha4kiran@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RAMAIAH MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: G952||Other and unspecified cord compression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PROPOFOL |
Intravenous Propofol will be used to maintain depth of anesthesia to titrate patient state index between 25 - 50 |
| Comparator Agent |
SEVOFLURANE group |
SEVOFLURANE to maintain depth of anesthesia at 1MAC |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 – 65 years
2.ASA 1 and 2
3.Elective thoracolumbar spinal surgeries
|
|
| ExclusionCriteria |
| Details |
1. Unable to insonate the MCA
2. Re exploration procedures
3. Carotid artery disease
4. Presence of intracranial pathology (intracranial space occupying lesions, meningitis, stroke, traumatic brain injury)
5. Intraoperative dye utilization or blood transfusion
6. Intraoperative SSEP and MEP recording
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To compare the cerebral blood flow (MCA velocity and PI using TCD) between Propofol and Sevoflurane based anaesthesia in prone position
2.To compare the cerebral oxygenation (rSO2 using NIRS) between Propofol and Sevoflurane based anaesthesia in prone position
|
The baseline Cerebral Hemodynamics and Oxygenation parameters will be recorded prior to Surgery, Using Transcranial doppler ultrasound (TCD) and Near infra red spectroscopy.After proning post induction of anesthesia recordings shall be taken every 15 minutes for the first 1 hour, then every 30 minutes for next 2 hours and hourly there after. final recordings shall be taken in the recovery room |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the outcome in terms of MMSE (Mini Mental State Examination) |
A baseline in the pre operative area and in the recovery room after extubation |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/09/2022 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prone position is frequently used for the surgical approach to the
spine. The physiological alterations due to prone position such as a decrease
in mean arterial pressure can lead to decreased cerebral perfusion pressure. However,
proning the patient has several advantages such as improved ventilation – leading
to increased cerebral oxygenation. Currently, Sevoflurane and Propofol are the
anaesthetic agents of choice for neurosurgical patients. Although both these
agents preserve cerebral autoregulation and maintain flow metabolism coupling,
their mechanism of action and effects on cerebral hemodynamics differ.
Transcranial doppler (TCD) is a simple, non-invasive bedside test which
measures the middle cerebral artery velocity (MCA) that is a surrogate marker
for cerebral blood flow. Near infrared spectroscopy (NIRS) gives a non-invasive
measurement of cerebral oxygenation. Hence, with the help of this study we want
to study the effect of these agents on cerebral hemodynamics (using TCD) and
cerebral oxygenation (using NIRS) in prone position. |