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CTRI Number  CTRI/2023/03/050517 [Registered on: 09/03/2023] Trial Registered Prospectively
Last Modified On: 09/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of supraglottic and subglottic addition of dexamethasone or dexmedetomidine for postoperative sore throat after general anaesthesia 
Scientific Title of Study   efficacy of supraglottic and subglottic instillation of dexamethasone or dexmedetomidine for the incidence and severity of postoperative sore throat after general anaesthesia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  sanjay kumar 
Designation  senior resident 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA -14 
Address  DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA
DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA
Patna
BIHAR
800014
India 
Phone  8804709874  
Fax    
Email  sanjay4ujnv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  mumtaz hussain 
Designation  additional professor 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA -14 
Address  DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA
DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA
Patna
BIHAR
800014
India 
Phone  9473376853  
Fax    
Email  drhussain72@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  sanjay kumar 
Designation  senior resident 
Affiliation  INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA -14 
Address  VILL- JAMALPUR MATHIYA P.O - NEW MOHAMMMAD PUR P.S - KOILWAR DIST. - BHOJPUR
DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA - 14
Bhojpur
BIHAR
802163
India 
Phone  8804709874  
Fax    
Email  sanjay4ujnv@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANAESTHESIOLOGY , 1ST FLOOR , WARD BLOCK , IGIMS , PATNA - 14 
 
Primary Sponsor  
Name  SANJAY KUMAR 
Address  DEPARTMENT OF ANAESTHESIOLOGY ,1ST FLOOR , WARD BLOCK, IGIMS PATNA - 14 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SANJAY KUMAR  IGIMS PATNA  first floor, neuro ot complex and gis ot complex
Patna
BIHAR 		 8804709874

sanjay4ujnv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IGIMS INSTITUTIONAL ETHICALCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  supraglottic and subglottic instillation of dexamethasone  supraglottic and subglottic instillation of dexamethasone 8mg diluted in normal saline to 5ml after intubation. patients will be followed for Incidence of sore throat, discomfort, pain and other symptoms will be assessed at the time of shifting to post-operative ward on 0hr,2hr, 4hr, 6hr, 12hrs & 24hrs. 
Comparator Agent  supraglottic and subglottic instillation of dexmedetomidine  supraglottic and subglottic instillation of Dexmedetomidine 100mcg diluted in normal saline to 5ml. patient will be followed for Incidence of sore throat, discomfort, pain and other symptoms will be assessed at the time of shifting to post-operative ward on 0hr,2hr, 4hr, 6hr, 12hrs & 24hrs. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  VALID CONSENT , ASA 1 AND 2 , MALLAMPATTI CLASS 1 & 2 , POSTED FOR SURGERY UNDER GENERAL ANAESTHESIA 
 
ExclusionCriteria 
Details  REFUSAL , ASA 3 OR MORE , AGE LESS THAN 18 YRS AND MORE THAN 65 YRS , HISTORY OF UPPER RESPIRATORY TRACT SENSITIVITY AND SORE THROAT , PREGNANCY , MORBID OBESITY , ICU TRANSFERRED PATIENTS WITH E.T TUBE IN SITU 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of supraglottic and subglottic Instillation of dexamethasone verses dexmedetomidine in decreasing the incidence and severity of post operative sore throat (POST) after general anaesthesia.  0, 2 hr, 4 hr, 6 hr, 12 hr, 24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the post operative hemodynamic stability, Pain on deglutition, Hoarseness, Cough or any other adverse effects.   0 , 2 hr , 4 hr , 6 hr , 12 hr , 24 hr 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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 2/ Phase 3 
Date of First Enrollment (India)   10/03/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

After enrolment in the study with the consent of the patients, they will be assessed preoperatively. All patients will be NPO 8 hrs before operation. All the subjects will be divided into two groups, Group A and Group B in the ratio of 1:1 according to random number table. All Patients and anaesthetists will be blinded to group assignments. On bringing the patient to operating room, base line recording of ECG, SBP, DBP, MBP, HR, RR will be measured using the monitor. The vein channel is to be established during a 18G indwelling needle. A simple face mask will be used for Oxygen for 3 minutes. Then anaesthesia will be induced through intravenous injection of 2ug/kg Fentanyl, 2mg/kg Propofol and 0.5mg/kg Atracurium/inj Vecuronium(0.1mg/kg). After three minutes of IPPV, intubation will be performed by direct laryngoscopy using appropriate size endotracheal tube. A single use high volume low pressure cuffed ETtube (Tuoren) containing supra & subglottic port for drug instillation will be used for intubation which will be fixed and inflated by 3-5ml of air.After securing ETtube a total volume of 5ml drug (8mg dexamethasone diluted in 3ml normal saline or 100mcg dexmeditomidine diluted in 3ml normal sline) will be given in supra & subglottic area through  supra & subglottic port of ET tube(Tuoren) .

 
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