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CTRI Number  CTRI/2026/01/100548 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 08/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Two Propofol Infusion Models to Control Anesthesia Depth in Kidney Transplant Patients 
Scientific Title of Study   Target controlled infusion of propofol: A comparison of two pharmacokinetic models in patients with end stage kidney disease undergoing kidney transplant surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIPIN KUMAR GOYAL 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Organ Transplant anaesthesia and Critical Care, Mahatma Gandhi Medical college & Hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290342890  
Fax    
Email  dr.vipin28@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  VIPIN KUMAR GOYAL 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Organ Transplant anaesthesia and Critical Care, Mahatma Gandhi Medical college & Hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290342890  
Fax    
Email  dr.vipin28@gmail.com  
 
Details of Contact Person
Public Query
 
Name  VIPIN KUMAR GOYAL 
Designation  Professor and Head 
Affiliation  Mahatma Gandhi Medical College and Hospital 
Address  Department of Organ Transplant anaesthesia and Critical Care, Mahatma Gandhi Medical college & Hospital, Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  8290342890  
Fax    
Email  dr.vipin28@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Hospital 
Address  Department of Organ Transplant anaesthesia and Critical Care Mahatma Gandhi Medical college and Hospital Jaipur Rajasthan 302022 
Type of Sponsor  Research institution and hospital 
 
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 Vipin Kumar Goyal  Mahatma Gandhi Medical College and Hospital  Department of Organ Transplant anaesthesia and Critical Care Mahatma Gandhi Medical college and Hospital Jaipur
Jaipur
RAJASTHAN 
8290342890

dr.vipin28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Mahatma Gandhi Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N186||End stage renal disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Propofol Target controlled infusion (TCI) models  TCI models- Schnider and Marsh  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with end stage kidney disease scheduled for kidney transplantation under general anesthesia 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is to see the effect of TCI model on induction of anaesthesia  induction of anaesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
The secondary outcomes are to observe anaesthesia recovery characteristics and any adverse events (hypotension, bradycardia, etc.)  during surgery 
 
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   N/A 
Date of First Enrollment (India)   01/02/2026 
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)  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  

This study will be conducted after obtaining ethics committee approval and signed informed consent.  We will enroll 60 patients with end stage kidney disease scheduled for              kidney transplantation under general anesthesia. Exclusion criteria will be age less than 20 years and more than 60 years, obesity (BMI >30 kg/m2), severe cardiac or respiratory disease, allergy to any components of propofol. Patients will be divided into two groups of 30 patients each and will be randomized in any group based on computer generated table of random numbers. Patients in group M will receive propofol infusion by modified Marsh model and in group S will receive by Schinder model of target-controlled infusion (TCI). Propofol will be infused with Mindray TCI pump in both the groups. On arrival in the operating room, an intravenous cannula will be secured into a peripheral vein of non-fistula arm. Routine monitoring including ECG, non-invasive blood pressure, pulse oximetry and BIS monitor will be attached, and baseline hemodynamic parameters will be recorded. Intravenous midazolam 1 mg and fentanyl 3 µg/kg will be given to all patients 2 minutes before the start of propofol infusion. Propofol TCI pump will be connected to the intravenous canula with running IV fluid. The effect site target of propofol will be set at 4 µg/ml and will be increased by 0.5 µg/ml every 30 seconds until there is loss of responsiveness to verbal command in both the groups. Loss of responsiveness will be checked by other anaesthesiologist who will be blinded to the research protocol. The anaesthesiologist will check for loss of responsiveness every 10 s after starting the propofol infusion. Loss of responsiveness will be defined as lack of response to the verbal command to open the eyes without touching the patient. Calculated effect-site concentration of propofol and BIS will be recorded when there is loss of responsiveness. In both groups, after loss of responsiveness trachea will be intubated on achievement of train of four response 0 after intubating dose of cisatracurium (2 mg/kg). After tracheal intubation effect site concentration of propofol will be set at 2.5 µg/ml to maintain BIS between 40-60 throughout the surgery. Infusion rate of propofol will be adjusted if BIS value is > 60 or < 40 for 1 minute by increasing or decreasing the target effect site concentration by 0.5 µg/ml in both group. Propofol infusion will be stopped on start of closure of surgical wound.  Effect site concentration of propofol on start of wound closure, BIS and time to return of responsiveness, duration of BIS < 40 and > 60, and total propofol consumption will be recorded. Mean arterial pressure and heart rate will be recorded at baseline, at loss of responsiveness, just after intubation and at return of responsiveness. Hypotension will be defined if MAP is less than 70 mmHg before reperfusion and less than 90 mmHg after reperfusion and bradycardia will be defined if HR goes below 60/minutes.  

 

 
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