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CTRI Number  CTRI/2021/03/032124 [Registered on: 18/03/2021] Trial Registered Prospectively
Last Modified On: 08/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Other (Specify) [BRAIN MRI]  
Study Design  Single Arm Study 
Public Title of Study   Correlation of Hippocampal Volume And Duration Of Emergence From General Anaesthesia In Neurosurgical Patients 
Scientific Title of Study   Correlation of Pre-Operative Hippocampal Volume Measured With Mri And Duration Of Emergence From General Anaesthesia In Elective Neurosurgical Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K Pramod 
Designation  Senior Resident 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care NIMHANS, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9535351200  
Fax    
Email  pramodkalgudi@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 Neuroanaesthesia and Neurocritical Care NIMHANS, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9448084257  
Fax    
Email  n_bhadri@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr K Pramod 
Designation  Senior Resident 
Affiliation  National Institute of Mental Health and Neurosciences 
Address  Department of Neuroanaesthesia and Neurocritical Care NIMHANS, Bengaluru

Bangalore
KARNATAKA
560029
India 
Phone  9535351200  
Fax    
Email  pramodkalgudi@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research [ICMR] V Ramalingaswami Bhawan P O Box No 4911 Ansari Nagar New Delhi 110029 India Fax: 91-11-26588662  
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  Indian Council of Medical Research V Ramalingaswami Bhawan PO Box No 4911 Ansari Nagar, New Delhi 110029 India 
Type of Sponsor  Research institution 
 
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 K Pramod  National Institute of Mental Health and Neurosciences  Department of Neuroanaesthesia and Neurocritical Care
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 
Intervention  Elective Brian And Spine Surgery Patients  Pre-operative hippocampal volume measured with mri and duration of emergence from general anaesthesia 
Comparator Agent  Elective Brian And Spine Surgery Patients  Pre-operative hippocampal volume measured with mri and duration of emergence from general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Patients above the age of 18 years who are scheduled for elective neurosurgical procedures 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 anaesthesia [8]
2.Patients having excision of hippocampus and amygdala.
3. Patients with temporal lobe pathology
4. Brain MRI [performed for the purpose of research] in patients undergoing spine surgery showing incidental brain pathology
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the correlation between preoperative hippocampus volume and duration of emergence after general anaesthesia  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 anaesthesia
 
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)   24/03/2021 
Date of Study Completion (India) 31/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2023 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
Kalgudi P, Bharadwaj S, Chakrabarti D, Bhadrinarayan V, Uppar AM, Prasad C. Correlation of Preoperative Hippocampal Volume Measured with Magnetic Resonance Imaging and Emergence from General Anaesthesia in Elective Neurosurgical Patients: An Observational Study 2024;72:1179-85. 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [pramodkalgudi@gmail.com].

  6. For how long will this data be available start date provided 01-03-2021 and end date provided 02-03-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
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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