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CTRI Number  CTRI/2023/06/053992 [Registered on: 16/06/2023] Trial Registered Prospectively
Last Modified On: 05/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   In patients undergoing elective surgery under General Anaesthesia, we will compare three drugs, intravenous Fentanyl, intravenous Dexmeditomidine & topical Lignocaine before induction with Propofol for their effectiveness in providing better comfort during Laryngeal mask airway insertion. 
Scientific Title of Study   A randomised double blinded study to compare the effectiveness of intravenous Fentanyl, intravenous Dexmeditomidine & topical Lignocaine for tolerance to Laryngeal mask airway insertion with Propofol induction. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rashmi Kumari 
Designation  Junior Resident  
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology and Critical Care Medicine, I.G.I.M.S

Patna
BIHAR
800014
India 
Phone  9905152996  
Fax    
Email  rashmirakri26@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rashmi Kumari 
Designation  Junior Resident  
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna 
Address  Department of Anaesthesiology and Critical Care Medicine, I.G.I.M.S

Patna
BIHAR
800014
India 
Phone  9905152996  
Fax    
Email  rashmirakri26@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nidhi Arun 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Sciences, Patna  
Address  Department of Anaesthesiology and Critical Care Medicine, I.G.I.M.S

Patna
BIHAR
800014
India 
Phone  9523594059  
Fax    
Email  janya.mukesh@yahoo.com  
 
Source of Monetary or Material Support  
Indira Gandhi Institute of Medical Sciences, Patna , Bihar, 800014 
 
Primary Sponsor  
Name  Indira Gandhi Institute of Medical Sciences ,Patna  
Address  Department of Anaesthesiology and Critical Care Medicine, I.G.I.M.S, Sheikhpura Patna, 800014 
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 
Rashmi Kumari  Indira Gandhi Institute of Medical Sciences, Patna  Department of Anaesthesiology and Critical Care Medicine , I.G.I.M.S, Sheikhpura 800014
Patna
BIHAR 		 9905152996

rashmirakri26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of ethics committee, IGIMS, Patna  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 
Comparator Agent  Intravenous Dexmeditomidine  Intravenous Dexmeditomidine 0.5mcg/kg diluted in 10 ml normal saline 
Comparator Agent  Intravenous Fentanyl  Intravenous fentanyl 2 mcg/kg diluted in 10 ml NS over 5 minutes. 
Intervention  Laryngeal mask airway insertion  Before induction in sitting position, GROUP D as well as GROUP F will receive 2ml normal saline via atomiser and GROUP L will receive 2ml 2% Lignocaine via atomiser. After that patient will put patient in supine position and preoxygention 3 minutes will be started and drugs will be given GROUP D will receive IV Dexmeditomidine 0.5mcg/kg in 10ml normal saline over 10 minutes, GROUP F will receive IV Fentanyl 2mcg/kg diluted in 10ml normal saline over 5 minutes and GROUP L will receive IV normal saline 10 ml over 5 minutes . Induction will be done with Propofol 2mg/kg before insertion of Laryngeal mask airway 
Comparator Agent  Topical Lignocaine  2 ml 2% lignocaine via atomiser  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age 18 to 60 years.
2.Both gender.
3.Patients with ASA physical status 1 and 2.
4.Posted for elective surgery under General Anaesthesia.
 
 
ExclusionCriteria 
Details  1.Patients with increased risk of aspiration.
2.Allergy to any of the study drugs.
3.Basal metabolic index >30 kg/m2.
4.Patient refusal.
5.Difficult airway and facial anomaly.
6.Patient with ASA physical status III & IV 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To acheive optimal condition for Laryngeal mask airway insertion.
Muzi & colleagues score less than or equal to 2 will be considered as optimal. 		 At the time of Laryngeal mask airway insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
To look for any side effects of study drugs.  During LMA insertion till 24 hours postoperative . 
Airway complications like sore throat & hoarseness of voice or any change in voice.  24 hrs postoperative  
 
Target Sample Size   Total Sample Size="147"
Sample Size from India="147" 
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 4 
Date of First Enrollment (India)   20/06/2023 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rashmirakri26@gmail.com].

  6. For how long will this data be available start date provided 05-06-2024 and end date provided 15-04-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The purpose of this study is to compare the effectiveness of three drugs, intravenous Fentanyl, intravenous Dexmeditomidine and topical Lignocaine before induction with Propofol in providing better comfort during Laryngeal mask airway insertion for securing airway and ventilation in patients undergoing elective surgery under General Anaesthesia. 
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