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CTRI Number  CTRI/2021/07/034647 [Registered on: 07/07/2021] Trial Registered Prospectively
Last Modified On: 07/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlation of patients hippocampal volume with recovery time after sedation in MRI unit 
Scientific Title of Study   Correlation of Hippocampal volume and recovery after propofol sedation in patients undergoing Magnetic Resonance Imaging 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Navyashree KS 
Designation  Senior resident 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical care NIMHANS, Hosur Road, near Dairy circle Bangalore
Hosur Road, Near Bangalore Milk Dairy, Bengluru, Karnataka - 5600029
Bangalore
KARNATAKA
560029
India 
Phone  9663950150  
Fax    
Email  drnavyashreeks@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhadrinarayan V  
Designation  Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical care NIMHANS, Hosur Road, Near Dairy circle, Bangalore
Hosur Road, Near Bangalore Milk Dairy, Bengluru, Karnataka - 5600029
Bangalore
KARNATAKA
560029
India 
Phone  9480829711  
Fax    
Email  n_bhadri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Navyashree KS 
Designation  Senior resident 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical care, NIMHANS, Hosur Road, Near Dairy circle, Bangalore
Hosur Road, Near Bangalore Milk Dairy, Bengluru, Karnataka - 5600029
Bangalore
KARNATAKA
560029
India 
Phone  9663950150  
Fax    
Email  drnavyashreeks@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  Hosur Road, Near Bangalore Milk Dairy, Bengluru, Karnataka - 5600029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Navyashree KS  National Institute of Mental Health and Neurosciences  Tesla MRI unit, Department of Neuroanesthesia and Neuro critical care, NIMHANS,Bangalore
Bangalore
KARNATAKA 
9663950150

drnavyashreeks@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMHANS Institure Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G96||Other disorders of central nervoussystem,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients who need sedation to undergo brain MRI, aged between 5 and 60 years.
Patients who will require both spine and brain MRI (with spine pathology).
Patients receiving sedation for 20 to 60 minutes duration. 
 
 
ExclusionCriteria 
Details  Refusal to provide informed consent
Patients with identified causes of delayed waking up like hypothyroidism, hyponatremia Na (<135 mEq/L) [3], hypernatremia Na >145 mEq/L [9], hypo/hyperglycemia, hypothermia with axillary temperature < 350C. 
Patients with known liver and/or renal dysfunction. (Defined as elevated or aspartate amino-transferase/ alanine amino-transferase > 5 times [10] when reports are available, serum creatinine >1.2 mg/dL) [11]
Patients on inotropic support.
Patients who are intubated.
Patients with motor component of Glasgow Coma Scale (GCS) ≤ 5 and eye component < 4 Patients diagnosed with intracranial space occupying lesions.
Patients post intracranial surgeries/ resection surgeries. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of recovery is made without any stimulation (tactile or noxious). Time to spontaneous eye opening and limb movement by the patients will be recorded from the time of stoppage of infusion.
The hippocampal volume will be calculated bilaterally in pre-contrast-volumetric MPRAGE sequence of brain imaging by the radiologist using Statistical Parametric Mapping.  
0, 5, 7, 9….. minutes from the stoppage of infusion ( i.e., 5 minutes after stoppage of the infusion, and every 2 minutes up to a point where the patient becomes fit for discharge ) 
 
Secondary Outcome  
Outcome  TimePoints 
assessment of adequacy to discharge will be assessed as per the Modified Aldrete Score which tests the activity level at request.  0, 5, 7, 9….. minutes from the stoppage of infusion ( i.e., 5 minutes after stoppage of the infusion, and every 2 minutes up to a point where the patient becomes fit for discharge ) 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   09/07/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

General anaesthesia is a drug-induced, reversible condition that includes specific behavioral and physiological components of unconsciousness, analgesia, and akinesia with concomitant stability of the autonomic, cardiovascular, respiratory, and thermoregulatory systems. 

Administration of a small dose of a hypnotic drug such like propofol, which acts on 

γ-aminobutyric acid type A (GABAA) receptors, induces a state of sedation in which the patient is calm and easily arousable, with the eyes closed. 

Arousal and maintenance of organized behavior during wakefulness is regulated by the central thalamus area of the ascending pathways from the brainstem and basal forebrain and descending pathways from the cortex. Studies have shown that the hippocampus too is a pivotal associated structure in the arousal pathway, and events that are seen post-operatively like delayed emergence, amnesia, post-operative delirium and post-operative cognitive decline can be attributed to the volume changes seen in hippocampus.
Delayed recovery /emergence from anaesthesia is the abnormally slow pace of regaining consciousness after general anaesthesia which is characterised by persistent somnolence. Delayed recovery remains one of the biggest challenges that anaesthesiologists are concerned with, as it requires additional time to analyse and use of extra resources. The delay in recovery of the patients from sedation leads to increased duration of stay in the post-procedure room, increases the need for additional monitoring and care and duration of hospital stay. 

Hippocampal electrical activity is shown to have direct correlation with sleep, wakefulness and arousal after anaesthesia. Several molecular and electrophysiological studies have shown that various factors ( sevoflurane/etomidate anaesthesia, temporal lobe resection leading to hippocampal atrophy in epilepsy patients ) affecting hippocampal cells or electrical activity causes delay in recovery from anaesthesia. Having established that, a recent study suggests that hippocampal volume correlates with the type of emergence from anaesthesia. As we are conducting a study which is exploratory in nature, based on the findings of the above mentioned studies studies, we hypothesised that delayed recovery after propofol sedation may be seen in patients with decreased hippocampal volumes.

The aim of our study is to correlate the hippocampal volumes and the duration of recovery and discharge after propofol sedation in the patients undergoing magnetic resonance imaging (MRI) from the post procedure observation room.




 
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