| 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 |
|
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Intervention |
Nil |
Nil |
|
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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
|
|
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Method of Generating Random Sequence
|
Not Applicable |
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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. |
|
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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 |
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Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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 |