| 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 |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
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Public Title of Study
|
Correlation of patients hippocampal volume with recovery time after sedation in MRI unit |
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Scientific Title of Study
|
Correlation of Hippocampal volume and recovery after propofol sedation in patients undergoing Magnetic Resonance Imaging |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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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 |
|
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Source of Monetary or Material Support
|
| National Institute of Mental Health and Neurosciences |
|
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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 |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Institure Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G96||Other disorders of central nervoussystem, |
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Intervention / Comparator Agent
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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.Â
|
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| 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.Â
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. |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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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 ) |
|
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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 ) |
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
none |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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