| CTRI Number |
CTRI/2026/02/104019 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A Study Comparing Two Anesthetic Drugs, Propofol and Sevoflurane, for Inserting a Breathing Mask in Children |
|
Scientific Title of Study
|
A Prospective Randomized Comparative Study of Induction with Propofol versus Sevoflurane for Laryngel Mask Airway in Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manhas Mittu Rajinder Singh |
| Designation |
Resident Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Department Of Anesthesiology and Critical Care, 3rd Floor, Pacific Medical College and Hospital, Bhilon Ka Bedla, Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9850622497 |
| Fax |
|
| Email |
mittumanhas92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramakant |
| Designation |
Professor Of Department Of Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital, Udaipur |
| Address |
Department of Anesthesiology and Critial Care, Pacific Medical College and Hospital, Bhilon ka Bedla, Udaipur, Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
8058021697 |
| Fax |
|
| Email |
dr.rkbhul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramakant |
| Designation |
Professor Of Department Of Anesthesiology |
| Affiliation |
Pacific Medical College and Hospital, Udaipur |
| Address |
Department of Anesthesiology and Critial Care, Pacific Medical College and Hospital, Bhilon ka Bedla, Udaipur, Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
8058021697 |
| Fax |
|
| Email |
dr.rkbhul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, 3rd Floor, Pacific Medical College and Hospital, Bhilon ka bedla, Udaipur - 313001, Rajasthan. |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital, Udaipur |
| Address |
Department of Anesthesiology and Critical Care, 3rd Floor, Pacific Medical College and Hospital, Bhilon ka bedla, Udaipur - 313001, Rajasthan. |
| Type of Sponsor |
Private 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 |
| Dr Manhas Mittu Rajinder Singh |
Pacific Medical College and Hospital |
Pacific Medical College and Hospital, Department Of Anesthesiology and Critical Care,Bhilon ka Bedla, Udaipur-313001
Udaipur
RAJASTHAN |
9850622497
mittumanhas92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College & Hospital Udaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, (2) ICD-10 Condition: N430||Encysted hydrocele, (3) ICD-10 Condition: N471||Phimosis, (4) ICD-10 Condition: O||Medical and Surgical, (5) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inhalation Sevoflurane |
Sevoflurane 7% inhalational in 100% oxygen via face mask at a total gas flow of 6 its per minutes will get given during Induction. The sevoflurane concentration will be increased to 1% when movement will occur. |
| Comparator Agent |
Injection Propofol |
Inj Propofol 2.5mg/kg iv Bolus will be given in Children of Age Group 2 -12 Years over 30 seconds. During Induction when child moved additional bolus of 1mg/kg of propofol will be given. |
| Intervention |
Laryngeal Mask airway |
Laryngeal Mask Airway according to age and weight of the child will be used after Induction with injection propofol or inhalational agent sevoflurane. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesia Grade 1 and 2.
Schedule for minor Elective surgery under General Anesthesia requiring Laryngeal Mask Airway insertion.
Obtained Informed consent from Parents or Legal Guardian. |
|
| ExclusionCriteria |
| Details |
Refusal of consent.
Known or suspected difficult Airway.
Upper respiratory tract infection within thebpast 2 weeks.
Known allergy to Propofol, sevoflurane or Laryngeal Mask Airway components.
Neurological or neuromuscular disorders, severe cardiopulmonary diseases.
Oropharyngeal pathology.
At risk of aspiration. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare time and attempts for Laryngeal Mask Airway insertion. |
Vital parameters will be recorded at baseline,at Induction, after insertion of Laryngeal Mask Airway at 2 minutes, 5 minutes, 10 minutes and then every 15 minutes till complete recovery from Anaesthesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess hemodynamic changes.
Eg Heart rate, Blood Pressure, spO2. |
Will be assessed at Baseline , 2 minutes, 5 minutes, 10 minutes, 15 minutes then every 15 minutes till complete recovery from anaesthesia. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
25/02/2026 |
| 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="1"
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
|
To compare the efficacy and safety of intravenous propofol versus inhalational sevoflurane for Induction of anaesthesia with respect to ease of Laryngeal Mask Airway in pediatric patients. |