FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017382 [Registered on: 01/02/2019] Trial Registered Prospectively
Last Modified On: 16/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to compare the effects of nebulisation with Lignocaine and Ketamine in reducing rise in blood pressure and heart rate during intubation and in reducing incidence of sore throat in post operative period  
Scientific Title of Study   COMPARISON OF NEBULIZED LIGNOCAINE AND NEBULIZED KETAMINE AS AN ADJUVANT TO GENERAL ANAESTHESIA IN ATTENUATING STRESS RESPONSE TO INTUBATION AND IN REDUCING THE INCIDENCE OF POSTOPERATIVE SORE THROAT 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Viji S Pillai 
Designation  Associate Professor 
Affiliation  Regional Cancer Centre, Thiruvananthapuram 
Address  PKRA 74, Midhunam parottukonam, Pattom, Thiruvanathapuram

Thiruvananthapuram
KERALA
695004
India 
Phone  9447304631  
Fax    
Email  vijipillai6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Viji S Pillai 
Designation  Associate Professor 
Affiliation  Regional Cancer Centre, Thiruvananthapuram 
Address  PKRA 74, Midhunam parottukonam, Pattom, Thiruvanathapuram

Thiruvananthapuram
KERALA
695004
India 
Phone  9447304631  
Fax    
Email  vijipillai6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anila V B 
Designation  Junior Resident 
Affiliation  Regional Cancer Centre, Trivandrum 
Address  Doctors Hostel, Regional Cancer Centre, Medical college campus, Trivandrum
Anila Nivas, Thekkethara, Pazhayannur, Thrissur
Thiruvananthapuram
KERALA
695011
India 
Phone  7034044192  
Fax    
Email  anilavaliyakath123@gmail.com  
 
Source of Monetary or Material Support  
Regional Cancer Centre, Trivandrum 
 
Primary Sponsor  
Name  Dr VIJI S PILLAI 
Address  PKRA 74, MIDHUNAM PAROTTUKONUM, PATTOM,TRIVANDRUM 
Type of Sponsor  Other [Self] 
 
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 Viji S Pillai  Regional Cancer Centre, Thiruvananthapuram  Department of Anaesthesiology, oncosurgery division, Regional cancer center, Medical College Campus, Thiruvananthapuram
Thiruvananthapuram
KERALA 		 9447304631

vijipillai6@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethic Committee, RCC Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ketamine  An anaesthetic agent which can be given in nebulised form to suppress airway reflexes Dose: 1 mg/kg upto a maximum of 50 mg 
Intervention  Lignocaine  A local anaesthetic agent which can be given in nebulised form to suppress airway reflexes Dose: 3 mg/kg 60 minutes prior to induction 
Comparator Agent  Normal saline  Intravenous fluid which can humidify the airway 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA physical status 1 and 2
Elective surgeries
Surgeries requiring General Anaesthesia with endotracheal intubation
Surgeries in supine position

 
 
ExclusionCriteria 
Details  Surgeries lasting for more than 4 hours
Known allergy to Lignocaine or Ketamine
Recent history of cough or sore throat
Nasal or oral surgeries
Anticipated difficult airway
Pregnancy
Obesity, BMI>30
Uncontrolled hypertension 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficiency of Lignocaine airway nebulisation and Ketamine nebulisation in attenuating stress response to intubation  To compare the efficiency of Lignocaine airway nebulisation and Ketamine nebulisation in attenuating stress response to intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the reduction in incidence of postoperative sore throat with use of Lignocaine and Ketamine nebulisation  24 hours after surgery 
 
Target Sample Size   Total Sample Size="164"
Sample Size from India="164" 
Final Enrollment numbers achieved (Total)= "162"
Final Enrollment numbers achieved (India)="162" 
Phase of Trial
Modification(s)  		 Phase 3/ Phase 4 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 20/09/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 A randomized clinical trial to compare the efficacy of Lignocaine(3 mg/kg) nebulisation and Ketamine nebulisation(1 mg/kg) in reducing stress response to intubation and post operative sore throat in patients requiring General Anaesthesia with endotracheal intubation. Sample size was 162 (54 in each group).
From the study we concluded that nebulization with ketamine and lignocaine are equally effective in reducing hemodynamic stress response and post operative sore throat following endotracheal intubation. There was marked rise in hemodynamic parameters and incidence of postoperative sorethroat in control group (normal saline nebulisation). 
 
Close