FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/088002 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 17/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Machine controlled versus Manual controlled propofol delivery for below umbilical surgery in children. 
Scientific Title of Study   A PROSPECTIVE OBSERVATIONAL STUDY TO COMPARE QUALITY OF ANAESTHESIA, DOSE, AND RECOVERY WITH TARGET VERSUS MANUAL CONTROLLED INFUSION OF PROPOFOL FOR INFRAUMBILICAL SURGERY IN CHILDREN. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAKTHI NARENDRAN 
Designation  JUNIOR RESIDENT DOCTOR 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  1202, EXCEL RESIDENCY, SEC 7, OPP TO SBI AIROLI, NAVI MUMBAI
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI, MAHARASHTRA PIN CODE 400022
Mumbai
MAHARASHTRA
400708
India 
Phone  9619894829  
Fax    
Email  sakthinarendran10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr ANILA D MALDE 
Designation  HEAD OF THE DEPARTMENT OF ANESTHESIOLOGY 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  ROOM NO 424, 4th FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI, MAHARASHTRA PIN CODE 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr ANILA D MALDE 
Designation  HEAD OF THE DEPARTMENT OF ANESTHESIOLOGY 
Affiliation  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL 
Address  ROOM NO 424, 4th FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION WEST, MUMBAI, MAHARASHTRA PIN CODE 400022
Mumbai
MAHARASHTRA
400022
India 
Phone  9821085730  
Fax    
Email  dradmalde@yahoo.com  
 
Source of Monetary or Material Support  
LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION WEST, MUMBAI 400022 
 
Primary Sponsor  
Name  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL 
Address  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND GENERAL HOSPITAL, SION WEST, MUMBAI 400022 
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 SAKTHI NARENDRAN  LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE  ROOM NO 424, 4th FLOOR, DEPARTMENT OF ANAESTHESIOLOGY, LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND HOSPITAL, SION, MUMBAI, PIN 400022
Mumbai
MAHARASHTRA 
9619894829

sakthinarendran10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE HUMAN RESEARCH LOKMANYA TILAK MUNICIPAL MEDICAL COLLEGE AND MUNICIPAL HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 4||Measurement and Monitoring,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  All children between the age 3 years to 12 years, weight between 5-61 kg receiving either TCI (pedfusor) or MCI propofol anesthesia (MacFarlan protocol) for infraumbilical surgery with supraglottic airway device and caudal epidural or regional block

 
 
ExclusionCriteria 
Details  1.Those cases who do not have intravenous access before the surgery and require inhalational induction.
2.Those who need oral premedication prior to induction
3.TCI by any protocol other than Pedfusor
4.MCI by any protocol other than MacFarlan
5.Lack of parental consent
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare TCI versus MCI propofol with respect to the
1.Quality of anaesthesia measured by frequency of boluses of propofol needed and number of times infusion pump setting has to be changed in response to surgical stimulus and hemodynamic changes
2.Ease of use by Anaesthetist
3.Satisfaction by the surgeons
 
Baseline post procedure 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare TCI versus MCI propofol infusion in terms of:
1. Total dose requirement
2. Recovery time
 
At the end of the surgery. 
 
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)   05/06/2025 
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="0"
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  

Propofol is an intravenous anesthetic agent used for both the induction and maintenance of general anaesthesia. The aim when using propofol in this way is to infuse it at a suitable rate, with additional boluses as needed, to achieve an effective blood concentration that corresponds to the level of surgical stimulation. Various methods, such as Manual Controlled Infusion (MCI) and Target Controlled Infusion (TCI), have been suggested for delivering propofol in Total Intravenous Anaesthesia (TIVA). 

 MCI involves an anaesthesiologist manually operating the infusion pump by setting a flow rate based on the prescribed dose and the patient’s condition. The McFarlan method is commonly used, involving an induction dose of 2.5 mg/kg followed by maintenance doses that vary over time: 15 mg/kg/hr for the first 15 minutes, 13 mg/kg/hr from 15-30 minutes, 11 mg/kg/hr from 30 minutes to 1 hour, 10 mg/kg/hr from 1-2 hours, and 9 mg/kg/hr for 2-4 hours

 TCI uses a theoretical approach described by Kruger-Thiemer to achieve and maintain a steady-state concentration of a drug with pharmacokinetics described by a multicompartmental model. the Pedfusor model is used to maintain a Cp value of 4-8 mcg/ml initially, followed by adjustments according to the needs of the surgery and response to stimuli.

In this study children undergoing infraumbilical surgeries who receive general anaesthesia with caudal epidural/regional anaesthesia will be observed. Nil by Mouth (NBM) status assessed. The child is taken to the operating room (OT). Standard ASA monitors are attached, and an initial reading of all parameters is noted. Fentanyl (2 mcg/kg) is administered through a patent IV line. After tying a tourniquet proximal to the IV-line, 1 mg/kg of preservative-free lignocaine is given. The tourniquet is then released. Anaesthesia is induced 5 minutes after administering fentanyl using the intravenous induction agent propofol, either through a TCI Pedfusor model or an MCI pump.

No neuromuscular blocking agent is given. When the appropriate depth of anaesthesia is achieved, a supraglottic airway device (SGAD) is inserted, and any response to the SGAD is noted. The patient is then connected to assisted mode ventilation with appropriate fresh gas flow (O2 + air), a tidal volume of 5-7 ml/kg, and a respiratory rate according to age. Age-appropriate regional block is administered following all aseptic precautions. Infusions are stopped, and the child is allowed to remove the SGAD.

Parameters to be assessed:

• Preoperative vitals (HR, SBP, DBP, SPO2)

 • Post induction vitals (HR, SBP, DBP, SPO2)

• Total Propofol dose in mg/kg/hr including the initial bolus given in MCI Induction

 • Quality of anaesthesia (number of boluses given and no of times the infusion rate has been changed as a result of patient’s response to stimuli and hemodynamic changes)

 • Recovery

• Ease of usage as per Anaesthesiologist (Excellent, good, fair poor)

 • Satisfaction of quality of anaesthesia as per surgeons (excellent, good, fair, poor)

• Need for additional inhalational or intravenous anaesthesia agent


 
Close