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CTRI Number  CTRI/2025/01/079312 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 22/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing pain relief methods for airway insertion during surgery 
Scientific Title of Study   A randomized clinical comparative study to observe intravenous fentanyl versus Topical lignocaine for Prosealâ„¢ laryngeal mask airway insertion with propofol induction. 
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 Maina Singh 
Designation  Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maina Singh 
Designation  Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Maina Singh 
Designation  Professor 
Affiliation  JLN medical college and hospital, Ajmer 
Address  Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan

Ajmer
RAJASTHAN
305001
India 
Phone  9414097045  
Fax    
Email  mainasingh111@gmail.com  
 
Source of Monetary or Material Support  
Department of anaesthesiology, JLN medical college and hospital, Ajmer, Rajasthan 305001 
 
Primary Sponsor  
Name  JLN medical college and hospital  
Address  Kala bagh, Ajmer, Rajasthan 305001 
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 Roop Singh Rawat  JLN medical college and hospital  Department of anesthesia, new OT, first floor, JLN hospital, Kala bagh, Ajmer, Rajasthan
Ajmer
RAJASTHAN 		 9799931514

dr.roopsinghrawat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethecal committee Jawarlal Nehru medical college, Ajmer  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  fentanyl  GROUP A 30 Patients will receive normal saline Spray in their posterior pharyngeal wall and fentanyl 2 microgram per kilogram in normal saline (total 10 milliliter volume) intravenously. 
Comparator Agent  lignocaine  GROUP B 30 Patients will receive topical lignocaine spray 40 milligram in their posterior pharyngeal wall and normal saline (total 10 ml volume) intravenously 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Able to give consent for procedure
2 ASA Grade first & second
3 Age group 18- 60 yrs.
4 Mallampati grade first & second
5 Undergoing general anaesthesia for elective surgeries which were less then 90 mins
duration.
6 Fasting more then 8 hours
7 BMI less then 30 
 
ExclusionCriteria 
Details  1 Patient refusals
2 ASA grade 3,4,5
3 Mouth opening less then 2.5 centimeter
4 Thyromental distance less then 4cm
5 Patients with poor lung compliance
6 Patients with cardiac disease, renal disease and hepatic disease
7 Known anatomical laryngotracheal anomaly
8 Undergoing emergency surgery
9 Fasting status doubtful
10 BMI more then 30
11 H/O of GERD 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Proseal LMA insertion conditions.  Baseline to 5 minute 
 
Secondary Outcome  
Outcome  TimePoints 
-Incidents of side effects (such as coughing, gagging, laryngospasm,
body movement, and apnea).

-Hemodynamic changes during the induction of the anesthesia. 		 Baseline 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/02/2025 
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="6"
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  
To compare the effect of  topical lignocaine versus intravenous Fentanyl for proseal LMA insution, took sample size of  60 prients, with 30 patients in each group.

Group A patients will recieve Normal saline spray in Posterior Pharyngeal wall & injection fentanyl 2mcg/kg intravenously.

Group B patients will recieve Topical lignocaine spray in posterior pharyngeal  & Normal saline intravenously.

Then patients will be induced by Inj Propofol 2mg/kg. & PLMA will be inserted. 
Occurrence of coughing, gagging , laryngospasm or body movement will be recorded. If these phenomenon  are absent it will  be optimal proseal LMA insertion . If these are present and proseal LMA could not be inserted in its first attempt  it is not optimal proseal LMA insertion.
 
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