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CTRI Number  CTRI/2019/08/020907 [Registered on: 26/08/2019] Trial Registered Prospectively
Last Modified On: 23/08/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Nebulization before giving anaesthesia to reduce the post surgery pain in throat.  
Scientific Title of Study   Effect of Nebulization with dexmedetomidine on post-operative sore throat: A prospective randomized controlled study  
Trial Acronym   
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anudeep Jafra 
Designation  Assistant Professor  
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia 4th floor B block Nehru Hospital, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  919888027699  
Fax    
Email  anu_gmch@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Anudeep Jafra 
Designation  Assistant Professor  
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia 4th floor B block Nehru Hospital, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  919888027699  
Fax    
Email  anu_gmch@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anudeep Jafra 
Designation  Assistant Professor  
Affiliation  Post Graduate Institute of Medical Education and Research 
Address  Department of Anaesthesia 4th floor B block Nehru Hospital, Post Graduate Institute of Medical Education and Research

Chandigarh
CHANDIGARH
160012
India 
Phone  919888027699  
Fax    
Email  anu_gmch@yahoo.co.in  
 
Source of Monetary or Material Support  
Post Graduate Institute of Medical Education and Research, sector 12, Chandigarh,160012 
 
Primary Sponsor  
Name  Post Graduate Institute of Medical Education and Research 
Address  sector 12, Chandigarh 
Type of Sponsor  Research institution and hospital 
 
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 Anudeep Jafra  Post Graduate Institute of Medical Education and Research  Department of Anaesthesia and Intensive Care, main operation theatre complex
Chandigarh
CHANDIGARH 		 919888027699

anu_gmch@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nebulization (inhalational) with 0.5micrograms/kg (3ml volume), dexmedetomidine for 15 mins  patients undergoing laparoscopic cholecystectomy would be nebulized with dexmedetomidine preoperatively 
Comparator Agent  nebulization (inhalational) with 3ml normal saline, for 15 mins  patients undergoing laparoscopic cholecystectomy would be nebulized using normal saline pre operatively 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American Society of Anesthesiologists physical status I and II patients
who are scheduled for elective laparoscopic surgery under general anaesthesia with endotracheal intubation 
 
ExclusionCriteria 
Details  Exclusion criteria will include patients with pre-operative sore throat, asthma, known case of chronic obstructive pulmonary disease, oral or head and neck surgery, recent non-steroidal anti-inflammatory drug therapy and mallampati grade >2 and more than 2 attempts of intubation. 
 
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 
Incidence of POST 4hours after extubation  Incidence of POST 4hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of POST immediately after extubation and post operatively (0,2,8,12,24 hrs), severity of POST post operatively (0,2,4,8,12,24hrs). Post-operative nausea vomiting, coughing episodes till 15 minutes after extubation, side effects bradycardia, hypotension and respiratory depression.  0,2,4,8,12,24hrs post operatively 
 
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   N/A 
Date of First Enrollment (India)   30/08/2019 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Introduction

Postoperative sore throat following general anaesthesia with endotracheal intubation is a source of discomfort for the patient. The procedure of laryngoscopy and intubation can lead to pharyngeal mucosa injury leading to post-operative sore throat (POST). The incidence of POST after placement of endotracheal tube is estimated to be around 20-65%. Dexmedetomidine is an alpha 2 adrenergic agonist, it has shown to have anti-inflammatory effects, by inhibiting release of inflammatory mediators (tumor necrosis factor alpha and interleukin 1 beta). Hence, present study will be conducted to evaluate the anti-inflammatory and analgesic role of dexmedetomidine for attenuating the severity and incidence of post-operative sore throat after general surgery using endotracheal intubation.

 
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