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CTRI Number  CTRI/2025/10/095906 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 08/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two intravenous propofol anaesthesia models for weight reduction surgeries 
Scientific Title of Study   Comparison of Schnider versus Eleveld models for propofol target-controlled infusion anaesthesia in adult bariatric surgery: A randomised controlled study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madhu Meena 
Designation  Post graduate student 
Affiliation  Lady Hardinge Medical College 
Address  Room no 508 New Acadmic Block Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  9588929392  
Fax    
Email  meenamadhu420@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishant Kumar 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room No 508 Dept of Anaesthesiology New Academic Block Lady Hardinge Medical College

New Delhi
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Details of Contact Person
Public Query
 
Name  Dr Nishant Kumar 
Designation  Director Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room no 508 new acadmic block Lady Hardinge Medical College


DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
opration theatre 8th floor new ipd building Lady Hardinge Medical College and Associated Hospitals New Delhi 110001 India 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE New Delhi 110001 India 
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 Madhu Meena  Operation theatere  Opration theatere 8th floor New ipd building Lady Hardinge Medical college and Associated Hospitals
Central
DELHI 
9588929392

meenamadhu420@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Human Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E66||Overweight and obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Use of Eleveld model for propofol  Mean effective concentration of propofol at return of responsiveness [cep@ROR] Mean effective concentration of propofol at loss of responsiveness [cep@LOR] 2. Time to reach modified Aldrete score 9 3. Total propofol requirement (mcg/kg/min) during surgery. 4. Side effects like hypotension, hypertension, bradycardia, tachycardia 5. Occurrence of explicit recall 
Intervention  Use of Eleveld model of propofol  Mean effective concentration of propofol at return of responsiveness [cep@ROR] Mean effective concentration of propofol at loss of responsiveness [cep@LOR] 2. Time to reach modified Aldrete score 9 3. Total propofol requirement (mcg/kg/min) during surgery. 4. Side effects like hypotension, hypertension, bradycardia, tachycardia 5. Occurrence of explicit recall 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients in the age group of 18-65 yrs.
ASA II and III 
 
ExclusionCriteria 
Details  Any known allergy to psychotropic drugs used in the study.
Addiction to drugs and alcohol.
Chronic opioid therapy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Comparison of mean effective concentration of propofol at return of responsiveness
responsiveness[cep@ror] using Schnider versus Eleveldmodels of propofol
target controlled infusion anaesthesia in adult bariatric surgery. 
After induction at 0 min
Can be variable according to patients 
 
Secondary Outcome  
Outcome  TimePoints 
mean effective concentration of propofol at loss of responsiveness  At the time of induction at 0 min
Can be variable according to patients 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 4 
Date of First Enrollment (India)   23/10/2025 
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="1"
Months="1"
Days="27" 
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  
Bariatric surgery has emerged as a crucial intervention in the management of morbid obesity
offering significant long-term benefits in terms of weight reduction and improvement of
obesity related comorbidities. However, the anaesthetic management of patients undergoing
bariatric procedures presents unique challenges due to altered pharmacokinetics, increased risk
of airway complications and heightened sensitivity to anaesthetic agents. Inhalational
anaesthesia and total intravenous anaesthesia (TIVA) are both widely used techniques for
inducing and maintaining general anaesthesia. Inhalational agents such as sevoflurane and
desflurane offer ease of administration and rapid titration but may be associated with
postoperative nausea and vomiting (PONV) and environmental pollution. On the other hand,
TIVA—most commonly using propofol with or without adjuncts like remifentanil—provides
a smoother recovery profile, reduced PONV, and better haemodynamic stability in these
patients.
TIVA, especially when delivered via target-controlled infusion (TCI), allows for precise
control of drug concentration at the effect site. This is particularly beneficial in obese patients,
where altered pharmacokinetics can impact drug distribution and metabolism. Propofol a
widely used intravenous anaesthetic, is commonly administered using target -controlled
infusion systems to maintain stable anaesthesia. These systems rely on pharmacokinetics
models to predict drug concentration and guide infusion rates. Amongst the various models
developed the Schnider and Eleveld effect site models are two prominent TCI frameworks
employed in clinical practice. The Schnider model, established earlier, is tailored primarily for
average weight adults, while the more recent Eleveld model is population based and designed
to accommodate a broader range of patient characteristics including age weight and lean body
mass -making it potentially more suitable for obese patients4 which may not be available in all
TCI pumps. Weight correction formula for the same model is CBW=IBW+[0.4×(TBW
IBW). Although the Schnider model uses fixed ke0 while Eleveld uses variable ke0 based on
covariates like age and weight, weight correction formula has been derived for use with the
Schnider model and is widely used in the absence of Eleveld model.

LACUNAE IN EXISTING KNOWLEDGE
The Schnider model is designed to be a universal model across a broad population, however
real-world clinical validation specifically in morbidly obese patients undergoing bariatric
surgery is still limited. Similarly, despite the theoretical advantages of the Eleveld model in the
bariatric populations, there is a lack of robust clinical evidence directly comparing its
performance with the Schnider model in this specific group. This study aims to evaluate and
compare the efficacy, safety and recovery profiles of propofol TCI guided by the Eleveld versus
the Schnider model in adult patients undergoing bariatric surgery.
 
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