| CTRI Number |
CTRI/2025/07/091898 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two different drugs for insertion of airway device. |
|
Scientific Title of Study
|
Randomized Double Blind Study To Evaluate The Comparison Of Ease Of
Insertion Of Laryngeal Mask Airway In Children With Ketamine -
Propofol And Fentanyl – Propofol. |
| 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 KAMAL JYOTI KASHYAP |
| Designation |
PROFESSOR |
| Affiliation |
Government medical college amritsar |
| Address |
Department of Anaesthesiology and Intensive care
Government medical college
Amritsar
Punjab
143001
Amritsar
PUNJAB
143001
India |
| Phone |
9878883727 |
| Fax |
|
| Email |
gauryanheerak@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KAMAL JYOTI KASHYAP |
| Designation |
PROFESSOR |
| Affiliation |
Government medical college amritsar |
| Address |
Department of Anaesthesiology and Intensive care
Government medical college
Amritsar
Punjab
143001
Amritsar
PUNJAB
143001
India |
| Phone |
9878883727 |
| Fax |
|
| Email |
gauryanheerak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KAMAL JYOTI KASHYAP |
| Designation |
PROFESSOR |
| Affiliation |
Government medical college amritsar |
| Address |
Department of Anaesthesiology and Intensive care
Government medical college
Amritsar
Punjab
143001
Amritsar
PUNJAB
143001
India |
| Phone |
9878883727 |
| Fax |
|
| Email |
gauryanheerak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Amritsar-143001, Punjab, India |
|
|
Primary Sponsor
|
| Name |
Dr Kamal jyoti kashyap |
| Address |
Department of Anaesthesiology and Intensive care, Government
Medical College, Amritsar-143001 (Punjab), India |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR ANU SHARMA |
Department of Anaesthesiology and Intensive care
Government Medical College
Amritsar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ATHIRA N G |
guru nanak dev hospital amritsar |
DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE, GOVERNMENT MEDICAL COLLEGE
AMRITSAR
Amritsar
PUNJAB |
09539550220
athiraganesh17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
, , (1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP PK PROPOFOL KETAMINE GROUP |
we will give injection propofol and ketamine to the 40 patients in this group and will be looked for LMA insertion ease and hemodynamic stability.we will also look for post operative complications like sore throat, dysphagia, hoarsness of voice. |
| Comparator Agent |
group propofol fentanyl (PF) |
we will give inj propofol and fentanyl to 40 patients in this group and will be looked for LMA insertion ease and hemodynamic stability. we will also look for post operative complications like sore throat, dysphagia and hoarsness of voice |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA grade 1 & 2
2 age 3 to 12 yrs
3 elective surgery of duration less than one hour |
|
| ExclusionCriteria |
| Details |
1 ASA 3 &4
2 patients at risk of aspiration
3 patient with airway abnormalities, anticipated difficult airway, pharyngeal pathology like abscesses, hematoma , tissue disruption
4 patient suffering from upper airway tract infection, reactive airway disease, asthmatic
5 seizure disorder , neuromuscular diseases
6 known egg allergy
7 patients giving refusal to participate in study
8 patients allergic to study drug
9 more than 3 failed attempts of LMA insertion in the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 TO compare and evaluate the ease of insertion for laryngeal mask airway with injection ketamine propofol and fentanyl propofol
2 Number of attempts of LMA insertion.
3 to compare the effect on hemodynamic parameters within the two groups |
LMA insertion ease NOTED AT TIME OF insertion of LMA
hEMODYNAMIC PARAMETERS will be observed at baseline, pre induction, pre LMA, 1 minute , 3minute and 5 minutes post LMA insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 to compare incidence of pharyngo laryngeal morbidity like cough vomiting laryngospasm blood stain on
LMA during removal
2 to compare the incidence of dysphagia sorethroat hoarsness of voice during recovery in post operative period |
During the removal of LMA & during the post operative period |
|
|
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
Modification(s)
|
N/A |
|
Date of First Enrollment (India)
|
08/08/2025 |
| 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="0"
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
|
LMA has become increasingly popular as an alternative for both endotracheal intubation and face mask ventilation as it induces fewer hemodynamic fluctuations. the present study aims to compare the ease of LMA insertion and hemodynamic stability in KETAMINE - PROPOFOL versus FENTANYL - PROPOFOL IN CHILDREN 80 patients of age between 3 - 12 years of either sex and ASA grade 1 & 2 will be randmoly divided into two groups of 40 patients each . group PK will receive inj ketamine followed by induction with Inj propofol . Group PF will receive Inj Fentanyl followed by Inj Propofol. Both the group will be compared for the ease of LMA insertion on the basis of 6 variables like head/limb movement, coughing / gagging, swallowing, resistance to mouth opening, resistance to insertion, laryngospasm . Number of attempts of LMA insertion will be noted. Hemodynamic parameters like BP, MAP.HR, RR , SpO2 will be noted at baseline, pre induction, pre LMA INSERTION, 1 MINUTE, 3 MINUTES, 5 MINUTES POST INSERTION. Any complications if any like sore throat, coughing, laryngospasm, hoarsness of voice, lacrimation, blood stain on LMA device will be noted during removal and during recovery |