| CTRI Number |
CTRI/2025/08/092673 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Fast vs. Usual Anesthesia Techniques to Help Place a Breathing Device More Easily in Children During Planned Surgeries |
|
Scientific Title of Study
|
Comparison of fast propofol bolus injection with conventional propofol & sevoflurane administration during anaesthesia induction for ease and proper placement of proseal lma in paediatric patients undergoing elective 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 |
SHIVANI |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no 301, 3rd floor, Department of Anaesthesia, ABVIMS & Dr.RML hospital, New Delhi
North
DELHI
110001
India |
| Phone |
9911245770 |
| Fax |
|
| Email |
shivaniudhraja1111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ASHOK KUMAR |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room NO.301,3rd floor, Department of Anaesthesia, ABVIMS and Dr.RML HOSPITAL, CENTRAL DELHI
Central
DELHI
110001
India |
| Phone |
9968579158 |
| Fax |
|
| Email |
drashoknishad7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ASHOK KUMAR |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr.Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room NO.301,3rd floor, Department of Anaesthesia, ABVIMS and Dr.RML HOSPITAL, CENTRAL DELHI
Central
DELHI
110001
India |
| Phone |
9968579158 |
| Fax |
|
| Email |
drashoknishad7@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and DR.Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, near Gurudwara Bangla Sahib, Connaught Place New Delhi, Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
ABVIMS and Dr.Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia,ABVIMS and Dr.Ram Manohar Lohia Hospital,New Delhi-110001 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSHIVANI |
ABVIMS and Dr.Ram Manohar Lohia Hospital |
Room No.301,3rd floor,Department of Anaesthesia
Central
DELHI |
9911245770
shivaniudhraja1111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee,ABVIMS and Dr.RML Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventionally administered propofol-sevoflurane anaesthesia |
To compare the ease of LMA insertion in pediatric patients receiving conventional bolus propofol injection (2.5mg/kg) along with sevoflurane anaesthesia (1.5%) |
| Intervention |
Fast bolus propofol injection anaesthesia |
To compare the ease of LMA insertion in pediatric patients receiving fast bolus propofol injection anesthesia (2.5mg/kg)
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA –I/II
Elective surgery patients
|
|
| ExclusionCriteria |
| Details |
Known patients of CVS, CNS & Respiratory Disorders.
Congenital birth defects
Allergic to anaesthesia drugs.
Any airway obstruction like tumor .
Airway/oral surgery
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess ease of PLMA insertion in all the patients.
scoring system having components
1.Jaw opening
2.Ease of insertion
3.Coughing
4.Patients movements
5.Laryngospasm
6.Gagging
|
5 min after induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Tidal Volume (Inspired & expired) & NG tube insertion |
at 1min, 2 min, 3 min , 4 min 5min after PLMA insertion |
| Vitals (HR , MBP, SpO2) |
at 1min, 2 min, 3 min , 4 min 5min after PLMA insertion |
| Number of attempts taken |
till 5 minutes after induction of anaesthesia |
| Injury- if any |
5 min after PLMA insertion |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 aims to compare the fast bolus propofol injection anaesthesia with conventionally administeredpropofol sevoflurane anaesthesia induction for ease and proper placementof Proseal LMA in pediatrics patients undergoing elective surgery. Group A will receive fast bolus propofol injection whereas Group B will receive conventional propofol injection followed by sevoflurane. Pre Anaesthetically, all patients will undergo medical evaluation,consent is obtained and they are kept NPO 6 to 8 hours before sugery . Pre Operatively, baseline vitals will be recorded . Premedication includes atropine, midazolam, fentanyl, and lignocaine. Intra Operatively, oxygen will be administered and all monitors will be attached . Group A receives rapid IV bolus propofol. PLMA inserted 30 sec after loss of reflexes. Group B receives slower propofol injection along with sevoflurane and then PLMA inserted. PLMA insertion is judged based on ease, number of attempts and adequacy of ventilation. Failed insertion after 3 attempts lead to exclusion and ETT intubation. Hemodynamic parameters and complications are recorded. The study concluded after successfil PLMA placement, ater wihich surgery proceeds under standard general anaesthesia. |