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CTRI Number  CTRI/2020/01/022922 [Registered on: 23/01/2020] Trial Registered Prospectively
Last Modified On: 23/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two drugs for prevention of sore throat after laparoscopic surgery 
Scientific Title of Study   To compare the effectiveness of dexmedetomidine versus combination of lignocaine and dexamethasone on postoperative sore throat in patients undergoing elective laparoscopic surgery in Trendelenburg position  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Divya Abhishek Kishore 
Designation  DNB Traninee 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of anaesthesia and critical care; Major OT No 6;Third floor;Old building;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085

North West
DELHI
110085
India 
Phone  9997195375  
Fax    
Email  drabhi78@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manoj Bhardwaj 
Designation  Senior Consultant Anaesthesiologist 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of Anaesthesia, Operation Theatre Division; Room no 8;Third Floor;Rajiv Gandhi Cancer Institute and Research Centre; Sector 5; Rohini; Delhi

North West
DELHI
110085
India 
Phone  9968604220  
Fax    
Email  manojb8@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Divya Abhishek Kishore 
Designation  DNB Traninee 
Affiliation  Rajiv Gandhi Cancer Institute and Research Centre 
Address  Department of anaesthesia and critical care; Major OT No 6;Third floor;Old building;Rajiv Gandhi Cancer Institute and Research Centre Sector-5 ; Rohini ; New Delhi -110085


DELHI
110085
India 
Phone  9997195375  
Fax    
Email  drabhi78@gmail.com  
 
Source of Monetary or Material Support  
Rajiv Gandhi Cancer Institute and Research Centre;Sector-5; Rohini; Delhi-110085  
 
Primary Sponsor  
Name  Dr Divya Abhishek Kishore 
Address  Major OT;Rajiv Gandhi Cancer Institute and Research Centre;Sector-5; Rohini; Delhi-110085  
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 Abhishek Kishore  Rajiv Gandhi Cancer Institute and Research Centre   Operation Room no:8;Department of Anaesthesia;Operation Theatre Division;Third Floor ;Old Building
North West
DELHI 		 9891777777

drabhi78@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Rajiv Gandhi Cancer Institute and Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C679||Malignant neoplasm of bladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexamethasone-lignocaine combination  8mg dexamethasone with 1.5mg/kg body weight lignocaine diluted with normal saline to make 20 ml given over 10 mins starting 5 mins before intubation 
Intervention  Dexmedetomidine   1 microgram/kg body weight diluted with normal saline to make 20 ml given over 10 mins starting 5 mins before intubation 
Comparator Agent  Normal saline  20 ml over 10 mins starting 5 mins before intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  ASA physical status I-III,
Undergoing elective laparoscopic surgery in Trendelenburg position
Requiring endotracheal intubation
Duration of surgery>90minutes
Expected to remain admitted in the hospital for >24hours. 
 
ExclusionCriteria 
Details  Patients with preexisting sore throat/ hoarsen
· ASA physical status IV
· BMI > 30
· Vocal performer by occupation
· Recent or recurrent respiratory tract infection
·Risk of postoperative aspiration (obesity, pregnancy )
· Pain medications, corticosteroids ; calcium channel blocker
· 2nd and 3rd degree Heart block 
· Allergy to Study drugs
·Anticipated difficult intubation(Mallampati grade >2, difficult mask ventilation requiring oral/nasal airway, Cormack and Lehane grade III-IV) Intubation attempt >1
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative sore throat  15min,1h,6h,12h,24h 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative sore throat on swallowing  15min,1h,6h,12h,24h 
Bloodstain over endotracheal tube  30 sec post extubation 
Percentage of glottic opening score  2 seconds before endotracheal intubation 
Total morphine consumption  24h after surgery 
 
Target Sample Size   Total Sample Size="135"
Sample Size from India="135" 
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)   29/01/2020 
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="0"
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)?  

Brief Summary   This is a prospective , double blind, single centric, three arm, randomized controlled trial comparing two groups of anaesthetic drugs with eachother and with placebo for prevention of post operative sore throat in 135 adult patients of either sex undergoing elective laparoscopic surgery in Trendelenburg position. The patients shall be randomly allocated to either of the three groups D (1microgram/kg dexmedetomedine),group LS(ligocaine 1.5mg/kg+8mg dexamethasone),group N(normal saline). These drugs are expected to reduce the incidence and severity of post operative sore throat both at rest and during swallowing. The primary outcome measure is postoperative sore throat at 15mins, 1h, 6h,12h and 24h postoperatively. The secondary outcome measures are postoperative sore throat on swallowing at 15min, 1h, 6h, 12h and 24 h post operatively, total morphine consumption measured at 24h postoperatively, percentage of glottic opening score measured at 2sec before intubation and blood staining of  the endotracheal tube noted 30sec post extubation. 
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