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CTRI Number  CTRI/2020/02/023292 [Registered on: 13/02/2020] Trial Registered Prospectively
Last Modified On: 28/07/2022
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 MRI guided pre-operative hippocampal volume with the duration of emergence from general anesthesia in elective neurosurgical patients undergoing cranial surgeries: An observational study 
Scientific Title of Study   Correlation of pre-operative hippocampal volume measured with MRI and duration of emergence from general anesthesia in elective neurosurgical patients undergoing cranial surgeries: An observational study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suparna Baradwaj 
Designation  Associate Professor 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences, Bengaluru
Department of Neuroanesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences, Bengaluru
Bangalore
KARNATAKA
560029
India 
Phone  9535351200  
Fax    
Email  acharya.suparna@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 NEURO ANESTHESIA & NEURO CRITICAL CARE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
DEPARTMENT OF NEURO ANESTHESIA & NEURO CRITICAL CARE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
Bangalore
KARNATAKA
560029
India 
Phone  9535351200  
Fax    
Email  n_bhadri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  PRAMOD KALGUDI 
Designation  SENIOR RESIDENT DM STUDENT 
Affiliation  NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES 
Address  DEPARTMENT OF NEURO ANESTHESIA & NEURO CRITICAL CARE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
DEPARTMENT OF NEURO ANESTHESIA & NEURO CRITICAL CARE, NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCES
Bangalore
KARNATAKA
560029
India 
Phone  9535351200  
Fax    
Email  pramodkalgudi@gmail.com  
 
Source of Monetary or Material Support  
Department of Neuroanesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences, Bengaluru  
 
Primary Sponsor  
Name  NIMHANS HOSPITAL 
Address  Department of Neuroanesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences, Bengaluru  
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 
Pramod Kalgudi  National Institute of Mental Health and Neurosciences  Department of Neuroanesthesia and Neurocritical Care National Institute of Mental Health and Neurosciences
Bangalore
KARNATAKA 
9535351200

pramodkalgudi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Patients above the age of 18 years who are scheduled for elective cranial surgeries under general anaesthesia
2. Patients having preoperative MRI Brain [T1-MPRAGE sequence]
3. GCS of 15
 
 
ExclusionCriteria 
Details  1.Patients with
a. Hypothyroidism
b. GCS < 15
c. Emergence time beyond 1 hour after discontinuing anesthesia [8]
2.Patients having excision of hippocampus and amygdala
3. Patients with temporal lobe pathology
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between preoperative hippocampus volume and duration of emergence after general anesthesia  1 hour after the end of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the relationship between preoperative hippocampus volume and functional reserve of the patient with the time and pattern of emergence after general anesthesia  1 hour during recovery  
To evaluate if there exists a gender difference in patterns of emergence  1 hour during recovery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "125"
Final Enrollment numbers achieved (India)="125" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2020 
Date of Study Completion (India) 30/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/11/2021 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   [1]. Chen L, Xu M, Li GY, Cai WX, Zhou JX. Incidence, Risk Factors and Consequences of Emergence Agitation in Adult Patients after Elective Craniotomy for Brain Tumor: A Prospective Cohort Study. PLoS One. 2014:9(12): e114239 [2]. Friedman EB, Sun Y, Moore JT, et al. A conserved behavioral state barrier impedes transitions between anesthetic-induced unconsciousness and wakefulness: evidence for neural inertia. PLoS One. 2010; 5:e11903. [PubMed: 20689589] [3]. Jaakko W. LÃ¥ngsjo, Michael T. Alkire, et al. Returning from Oblivion: Imaging the Neural Core of Consciousness. The Journal of Neuroscience. 2012; 32(14):4935– 4943  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Duration and pattern of emergence from anesthesia is poorly investigated and understood. Traditionally, it has been assumed that the induction of and emergence from general anesthesia are mirror images of one another. The asymmetry—or “hysteresis”—of anesthetic concentrations required for induction vs. emergence has long been recognized but has been attributed to pharmacokinetic characteristics. Emerging evidence suggests that this asymmetry may reflect a distinct neurobiology of the two processes and that the neural circuits mediating induction do not entirely overlap with the neural circuits mediating emergence [2] .

The recovery from anesthesia does not occur all at once, but rather it appears to occur in a bottom-up manner.  Anatomically, there is activation of a core network involving subcortical and limbic regions (like hippocampus) initially upon emergence and later they become functionally coupled with parts of frontal and inferior parietal cortices. Physiologically, when emerging from deep anesthesia there will first be signs of autonomic arousal, followed by a slow return of brainstem reflexes, eventually leading to reflexive or uncoordinated movements that occur somewhat before subjects can willfully respond to simple commands. Thus, emergence of a conscious state, precedes the full recovery of neocortical processing required for establishing contact with the surroundings. Arousal (spoken command) induced brain activations during emergence from anesthesia are mostly localized in deep, phylogenetically old brain structures (limbic cortex or mesial temporal structures) than in neocortex [3].

The potential association between hippocampal volume and the time and pattern of emergence from anesthesia remains unclear [4,5]. A retrospective analysis of cohort data suggests that surgery may be associated with a decrease in brain volume (volume of limbic system) [6]. Also it is well known that subcortical and hippocampus form the core network during arousal after general anaesthesia [3]. However, no studies suggesting potential link between preoperative hippocampal volume and post anaesthesia recovery characteristics have been analyzed. 

            Apart from anatomical structures even functional components namely patient education, working and leisure activities are known to contribute to patient emergence characters [7]. These components determine the preexisting functional reserve of brain and its resistance to surgical or anesthetics stress. Hence, we would like to study the correlation of pre-operative MRI guided hippocampal volume and functional reserve with time and pattern of emergence after general anesthesia in elective neuro surgical procedures.

Hypothesis

Our hypothesis is that there will be correlation between the preoperative hippocampal volume and the time to emergence from general anaesthesia in neurosurgical patients.


 
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