| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pramodkalgudi@gmail.com].
- 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.
- 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 “hysteresisâ€â€”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. |