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CTRI Number  CTRI/2025/09/095240 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Comparison study 
Study Design  Other 
Public Title of Study   effect of anaesthesia depth on Motor evoked potentials in older adults during spine surgery 
Scientific Title of Study   Effect of BIS on motor evoked potentials in older adults in spine surgeries 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  kotlo rukminiseshadri 
Designation  fellow trainee neuroanaesthesia 
Affiliation  aster whitefield hospital 
Address  Aster whitefield hospital plot no 3 and 4 main road, off whitefield opposite ITPLmain road, Sadara mangala industrial area, whitefield Bengaluru, Karnataka 560066

Bangalore
KARNATAKA
560066
India 
Phone  9008310364  
Fax    
Email  rukminikotlo@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  kotlo rukminiseshadri 
Designation  fellow trainee neuroanaesthesia 
Affiliation  aster whitefield hospital 
Address  Aster whitefield hospital plot no 3 and 4 main road, off whitefield opposite ITPLmain road, Sadara mangala industrial area, whitefield Bengaluru, Karnataka 560066


KARNATAKA
560066
India 
Phone  9008310364  
Fax    
Email  rukminikotlo@gmail.com  
 
Details of Contact Person
Public Query
 
Name  dheeraj masapu 
Designation  head of neuroanasthesia 
Affiliation  aster whitefield hospital 
Address  Aster whitefield hospital plot no 3 and 4 main road, off whitefield opposite ITPLmain road, Sadara mangala industrial area, whitefield Bengaluru, Karnataka 560066

Bangalore
KARNATAKA
560066
India 
Phone  9591964327  
Fax    
Email  dheerajmasapu@gmail.com  
 
Source of Monetary or Material Support  
aster whitefield hospital bengaluru 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [Investigator Initiated Study] 
 
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 Kotlorukmini Seshadri  Aster Whitefield Hospital  Plot No. 3 & 4, Main Road, off Whitefield, opposite ITPL Main Road, Sadara Mangala Industrial Area, Whitefield, Bengaluru, Karnataka 560066
Bangalore
KARNATAKA 
9008310364

rukminikotlo@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AsterCMI Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G549||Nerve root and plexus disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  Inclusion Criteria:
1.Patients aged 65 years or older
2.Patients undergoing elective spinal surgery or other surgeries where MEP monitoring
is indicated
3.American Society of Anesthesiologists (ASA) physical status classification I-II 
 
ExclusionCriteria 
Details  1.Pre-existing neurological deficits affecting motor function
2.Contraindications to MEP monitoring (e.g., epilepsy, intracranial metal)
3.Severe cardiac conditions (e.g., severe coronary artery disease, heart failure).
4.Inability to provide informed consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will provide evidence on how sedation depth affects MEPs in older adults. The results will help identify the optimal sedation depth for reliable MEP monitoring in this population. The findings will contribute to improved patient safety and neurological outcomes during surgery.   once TRAIN OF FOUR RATIO greater than 75 percentage , the amplitude and latency of motor evoked potentials at three different bis levels will be measured at time interval of 5 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
comparison between decremental time in tci propofol pump after surgical closure and
time to patient awakening, hemodynamics at different depth of anaesthesia, post op neurologic deficits 
once TRAIN OF FOUR RATIO greater than 75 percentage , hemodynamic variables like , HeartRate, BloodPressure , at three different bis levels will be measured at time interval of 5 minutes  
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   01/10/2025 
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="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   Introduction
Intraoperative neurophysiological monitoring, especially motor evoked potentials, plays a crucial role in spine surgeries by providing real-time assessment of the functional integrity of motor pathways and helping to prevent neurological injury. MEPs are generated by transcranial electrical stimulation and recorded from peripheral muscles, but their reliability can be significantly affected by the depth of anesthesia. The bispectral index, derived from EEG analysis, is widely used to monitor anesthetic depth, with values ranging from 0 to 100. Anesthetic agents suppress cortical excitability and hence influence MEP responses. Studies have shown that lower BIS values, indicating deeper anesthesia, are associated with reduced MEP amplitudes and delayed latencies, while lighter anesthesia enhances MEP signal quality. Older adults present unique challenges in anesthetic management due to age-related alterations in pharmacodynamics and pharmacokinetics. Evidence suggests that elderly patients tend to have lower BIS values under similar anesthetic conditions compared to younger individuals, reflecting increased sensitivity to anesthetic agents. This heightened sensitivity could suppress cortical excitability further, potentially impairing MEP monitoring. Therefore, investigating the relationship between BIS guided anesthetic depth and MEP responses in older adults undergoing spine surgery is essential. Understanding this interaction may help optimize neurophysiological monitoring and improve surgical outcomes in the geriatric population.

Significance of the Study: 
This study will provide valuable data on how different depths of sedation affect MEPs in older adults. The findings will help refine anesthesia protocols and monitoring strategies, leading to: Improved accuracy of intraoperative neurological assessment Reduced risk of false-positive or false negative MEP findings Enhanced patient safety during surgical procedures The results may contribute to the development of age specific guidelines for MEP monitoring. 

Objectives 
Primary Objective To evaluate the effect of varying depths of sedation, measured using the Bispectral Index, in allowable range ,on the amplitude and latency of MEPs in older adult patients 
Secondary Objectives To assess the relationship between age-related physiological factors and MEP changes under different sedation depths. Decremental time reliability in TCI pump To determine the optimal BIS range for reliable MEP monitoring in older adults. 

Hypothesis Does BIS have any Effect on Motor Evoked Potentials in Older Adults in spine surgeries. 
Null hypothesis  There is no any Effect of BIS on Motor Evoked Potentials in Older Adults in spine surgeries.

Materials and Methods
Study Design Prospective Observational study 
Study Population Older Patients who were undergoing spine surgery will be recruited. 

Inclusion Criteria
1.Patients aged 65 years or older 
2.Patients undergoing elective spinal surgery or other surgeries where MEP monitoring is indicated 
3.American Society of Anesthesiologists physical status classification I to III 

Exclusion Criteria
1.Pre-existing neurological deficits affecting motor function 
2.Contraindications to MEP monitoring.
3.Severe cardiac conditions e.g., severe coronary artery disease, heart failure.

Anesthesia Protocol: Patients will receive total intravenous anesthesia with propofol and fentanyl to allow for controlled adjustment of sedation depth. Sedation depth will be titrated to target BIS levels of 40 to 45 deep sedation, 45-50 (moderate sedation), and 50-60 value. , a step-wise approach could be used, depending on the final study design and ethical considerations. Neuromuscular blocking agents will be avoided after intubation to prevent interference with MEP recording. MEP Monitoring: Transcranial electrical stimulation will be used to elicit MEPs. MEPs will be recorded from appropriate muscle groups using standard techniques. MEP amplitude and latency will be measured at baseline and at each target BIS level. Stimulation parameters will be optimized and kept constant throughout the monitoring period.

Sample Size Formula: 95 subjects.

Statistical analysis Collected data will be coded and entered into a Microsoft excel sheet. Qualitative data will be described as frequency and percentages and analysed by using chi square test. P value less than 0.05 considered stastically significant. Repeated measures ANOVA or mixed-effects models will be used to compare MEP parameters across different BIS levels. Correlation and regression analyses will be performed to assess the relationship between age, comorbidities, medication use, and MEP changes. 

Data Collection Patient demographics like age, sex, medical history, medications, ASA physical status, BIS values at specified time points, MEP amplitude and latency measurements and Surgical details will be collected. 

Expected Outcomes and Dissemination Expected Outcomes The study will provide evidence on how sedation depth affects MEPs in older adults. The results will help identify the optimal sedation depth for reliable MEP monitoring in this population. The findings will contribute to improved patient safety and neurological outcomes during surgery. 

Dissemination Plan Publication of results in peer-reviewed scientific journals Presentation of findings at national and international conferences Development of clinical guidelines or recommendations for MEP monitoring in older adults.
 
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