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CTRI Number  CTRI/2025/09/095329 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 23/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   An analysis of anaesthesia technique used for surgeries done for epilepsy patients in the past 
Scientific Title of Study   A Retrospective Analysis of Anaesthetic Management for Epilepsy Surgery with Intraoperative Neuromonitoring 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chris Leslie Lemos 
Designation  Assistant Professor Neuroanaesthesia 
Affiliation  Superspeciality Hospital NSCB Medical College 
Address  Department of Neuroanaesthesia room no.1 5th floor Superspeciality Hospital, NSCB Medical College, Tilwara road, Jabalpur

Jabalpur
MADHYA PRADESH
482001
India 
Phone  9373278417  
Fax    
Email  lemoschris24@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chris Leslie Lemos 
Designation  Assistant Professor Neuroanaesthesia 
Affiliation  Superspeciality Hospital NSCB Medical College 
Address  Department of Neuroanaesthesia room no.1 5th floor Superspeciality Hospital, NSCB Medical College, Tilwara road, Jabalpur


MADHYA PRADESH
482001
India 
Phone  9373278417  
Fax    
Email  lemoschris24@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chris Leslie Lemos 
Designation  Assistant Professor Neuroanaesthesia 
Affiliation  Superspeciality Hospital NSCB Medical College 
Address  Department of Neuroanaesthesia room no.1 5th floor Superspeciality Hospital, NSCB Medical College, Tilwara road, Jabalpur


MADHYA PRADESH
482001
India 
Phone  9373278417  
Fax    
Email  lemoschris24@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Netaji Subhash Chandra Bose Medical College 
Address  Doctors colony, Tilwara Road, Jabalpur, 482003, MP 
Type of Sponsor  Government medical college 
 
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 Chris Leslie Lemos  Superspeciality Hospital, NSCB Medical College  Department of Neuroanaesthesia room no.1 5th floor Superspeciality Hospital, NSCB Medical College, Tilwara road, Jabalpur
Jabalpur
MADHYA PRADESH 
9373278417

lemoschris24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethic Committee Netaji Subhash Chandra Bose Medical College Jabalpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G968||Other specified disorders of central nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  all patients who underwent surgery for drug resistant epilepsy 
 
ExclusionCriteria 
Details  Patients where appropriate documents and records not available 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the anaesthetic techniques used and any possible impact they may have on neuromonitoring  intraoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
to assess complications occurring in preoperative period
to assess 1 year follow up in recovery 
1 year 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   06/10/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  


A Retrospective Analysis of Anaesthetic Management for Epilepsy Surgery with 

Intraoperative Neuromonitoring



Introduction:


Approximately 65 million people are affected with epilepsy worldwide3.

Prevalence of epilepsy in India has been reported as 4.3 per 1000 population1. Approximately 30-35% of patients develop drug resistant epilepsy (DRE)2.

Drug resistant epilepsy has been defined by International League against Epilepsy (ILAE) task force as failure to respond to two tolerated, appropriately chosen and adequately tried anti-epileptic drugs (AEDs)4. Various modalities are available for surgically remediable lesions provided there is concordance between different investigation modalities. The surgical management and neurological complications in patients undergoing epilepsy surgery is documented in the literature, but anaesthetic course and perioperative complications are less well-described. Anaesthesia management varies with the type of surgical technique selected and hence poses additional challenges. To address the anaesthetic and preoperative challenges faced we seek to investigate the data of patients with DRE who underwent epilepsy surgery at our institute.


Aims and objectives:


  • To assess the anaesthetic techniques used and any possible impact they may have upon neuromonitoring
  • To assess complications occurring in perioperative period.



Justification:

There have been many advances in surgery for drug resistant epilepsy which demands appropriate changes in anaesthetic management as well.

With newer guidelines still emerging for epilepsy surgery, we would like to conduct retrospective analysis of our anaesthetic and surgical date which will help us in formulating newer protocols on department level and provide better preoperative care leading to favourable outcomes.


Methodology:


Design of study:

This study will be a retrospective comparative study


Study duration:

From Jan 2020 to July 2025


Selection of cases:


After obtaining approval from institutional ethic committee, the study will be conducted at Superspeciality hospital, NSCB Medical College, Jabalpur


All patients who meet our inclusion criteria will be enrolled.


Inclusion criteria:


  • Patients who have undergone surgery for drug resistant epilepsy


Exclusion criteria:


  • Appropriate records and documentation not available


Method of study:


This study will be conducted at Superspeciality hospital, NSCB Medical College, Jabalpur after approval of institutional ethics committee and review board. This retrospective comparative study will enrol all patients with appropriate documentation who have undergone surgery for drug resistant epilepsy between January 2020 to April 2022. Drug resistant epilepsy will be defined as patients refractory to two or more antiepileptic drugs in adequate doses for at least two years.

Demographic data like age, sex, weight, height and data related to illness, age of onset of seizures, duration of epilepsy, investigations done and  relevant history. Intraoperative data to be collected; type and duration of surgery, anaesthetic technique and duration used, use of supplementary scalp blocks, neuromonitoring used, complications and recovery from anaesthesia. Postoperative data to be collected; immediate complications like postoperative nausea and vommiting (PONV), secures, ventilation and use of AEDs perioperatively. Long term outcome will be assessed using Engel rating scale as free of disabling seizure (Engel class I), rare disabling seizure (Engel II), worthwhile improvement (Engel III), or no worthwhile improvement (Engel class IV).[5]


Statistical analysis:


Data will be collected using GraphPad Prism version 10.4.2 (633) for windows software. Mean, standard deviation (SD) and confidence intervals (CI) will be calculated in the three groups for measurable demographic data like age and weight. Inter-group and intra-group hemodynamic parameters at different time points will be assessed with repeated measure ANOVA (analysis of variance) test. Categorical data will be assessed with chi-square test.



Results and conclusions:


Results and conclusions will be drawn at the end of the study.



 
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