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CTRI Number  CTRI/2022/12/048256 [Registered on: 19/12/2022] Trial Registered Prospectively
Last Modified On: 20/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare between two combination of drugs dexmedetomidine and ropivacaine with budesonide and ropivacaine to check incidence of post operative sore throat after general anaesthesia. 
Scientific Title of Study   A comparative study of efficacy of intratracheal dexmedetomidine and ropivacaine with intratracheal budesonide and ropivacaine in incidence and severity of post operative 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  Harsh 
Designation  Post Graduate Student 
Affiliation  Indira Gandhi Institute of Medical Scienecs 
Address  First floor, Near Neuro OT, Department of Anaesthesiology and Critical Care Medicine, Indira Gandhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone  9470840038  
Fax    
Email  drharshpatna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Bibha Kumari 
Designation  Associate Professor 
Affiliation  Indira Gandhi Institute of Medical Scienecs 
Address  First floor, Near Neuro Ot Complex, Department of Anaesthesiology and critical care medicine, Indira Gandhi institute of medical sciences, Patna

Patna
BIHAR
800014
India 
Phone  8252410069  
Fax    
Email  drbibha98aditi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Harsh 
Designation  Post Graduate Student 
Affiliation  Indira Gandhi Institute of Medical Scienecs 
Address  First floor, Near Neuro Ot complex, Department of Anaesthesiology and critical care medicine, Indira GAndhi Institute of Medical Sciences, Patna

Patna
BIHAR
800014
India 
Phone  9470840038  
Fax    
Email  drharshpatna@gmail.com  
 
Source of Monetary or Material Support  
Indira Gandhi institute of medical science, Patna Bihar  
 
Primary Sponsor  
Name  Harsh 
Address  Department of Anaesthesiology, IGIMS, Patna Bihar 800014 
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 
Harsh  Indira Gandhi Institute of Medical Science  First floor, Near Neuro Ot complex, Department of Anaesthesiology and critical care.
Patna
BIHAR 		 9470840038

DRHARSHPATNA@GMAIL.COM 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, IGIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine, ropivacaine  Will be used in combination of two groups, group 1 is dexmedetomidine(1mcg/kg) and ropivacaine(0.75% 35mg in 5ml) with group 2 Budesonide(200mcg) and ropivacaine(0.75% 35 mg in 5ml) by intratracheal mode of instillation. Volume of drug in both group will be constant 7ml. After 3 min of preoxygenation after giving inducing agent Propofol(1.5mg/kg) and muscle relaxant Atracurium(0.5mg/kg) then under direct laryngoscopy spray 7ml of drug of group 1 or 2 ( double blind) in glottis and periglottic space and then again bag and mask vnetilation for next two minutes followed by endotracheal intubation under direct laryngoscopy 
Comparator Agent  Ropivacaine, Budesonide   Comparator agent is Group B which has combination of Budesonide 200mcg with Ropivacaine 0.75% 5ml making the total volume of drug to be 7ml and spray the drug in the glottic and the periglottic area followed by bag and mask ventilation for two minutes and then endotracheal intubation under direct laryngoscopy.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient of ASA 1 and ASA2 physical status
2. Patient between 18-65 years of age.
3. Patient with Mallampati class I-II.
4. Patient posted for major surgeries under General anaesthesia.
5. Patient wiling to participate. 
 
ExclusionCriteria 
Details  1. Patient refusal to participate.
2. Patient with ASA physical status III or above.
3. Patient aged less than 18 years and more than 65 years.
4. Patient with suspected difficult airway and Mallampati grade III or above.
5. Patient with pregnancy, morbid obesity and history of sore throat.
6. Patient transferred to ICU intubated after operation under general anaesthesia. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative sore throat, pain on deglutition, hoarseness and cough  Zero Hour(Just after Extubation, 2,4,6,12,24 hrs post extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative hemodynamics changes in heart rate, blood pressure, MAP, oxygen saturation   Before giving drug, before intubation, after intubation, after 15 min of surgery, after 30 minute of surgery, after Extubation  
 
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   N/A 
Date of First Enrollment (India)   02/01/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 09-11-2022 and end date provided 09-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary
Modification(s)  		 It is a prospective double blind trial to check the efficacy of two combination of drugs i.e. Ropivacaine and dexmedetomidine with ropivacaine and budesonide in incidence and severity of post operative sore throat after general anaesthesia. The mode of giving this combination of drug is Intratracheal just prior to intubation followed by preoxygenation and then intubating under direct laryngoscopy.  
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