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CTRI Number  CTRI/2020/06/025706 [Registered on: 08/06/2020] Trial Registered Prospectively
Last Modified On: 27/05/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To study the effectiveness of turmeric on prevention of sore throat due to passing of breathing tube into the wind pipe for genral anesthesia by taking turmeric chewable preparation orally and budesonide nebulisation before the operation. 
Scientific Title of Study   Efficacy of preoperative turmeric lozenge in addition with budesonide nebulisation on incidence of post operative sore throat – double blinded randomized placebo control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr R ARUNKUMAR 
Designation  POST GRADUATE 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SECOND FLOOR, HOSPITAL BLOCK, MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, SBV UNIVERSITY, PILLAIYARKUPPAM, PONDICHERRY.

Pondicherry
PONDICHERRY
607402
India 
Phone  8015211292  
Fax  04132615457  
Email  arunavr6@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr V R HEMANTH KUMAR 
Designation  PROFESSOR 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SECOND FLOOR, HOSPITAL BLOCK, MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, SBV UNIVERSITY, PILLAIYARKUPPAM, PONDICHERRY.

Pondicherry
PONDICHERRY
607402
India 
Phone  9003550553  
Fax  04132615457  
Email  drvrhk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr ARCHANA ARETI 
Designation  ASSISTANT PROFESSOR 
Affiliation  MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE 
Address  DEPARTMENT OF ANAESTHESIOLOGY, SECOND FLOOR, HOSPITAL BLOCK, MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, SBV UNIVERSITY, PILLAIYARKUPPAM, PONDICHERRY.

Pondicherry
PONDICHERRY
607402
India 
Phone  8374237095  
Fax  04132615457  
Email  archanaareti@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology Mahatma Gandhi medical college and research institute 
 
Primary Sponsor  
Name  DEPARTMENT OF ANAESTHESIOLOGY 
Address  SECOND FLOOR, HOSPITAL BLOCK, MAHATMA GANDHI MEDICAL COLLEGE AND RESEARCH INSTITUTE, SBV UNIVERSITY, PILLAIYARKUPPAM, PONDICHERRY. 
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 
R ARUN KUMAR  Mahatma Gandhi medical college and research institute  First floor D OT block and Second floor N OT block.
Pondicherry
PONDICHERRY 
8015211292

arunavr6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional human ethics committee of mahatma Gandhi medical college and research institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo lozenge  The patients will recieve one lozenge at 8pm at night of before surgery and aother one at morning one hour before the surgery and budesonide nebulisation 10mins before intubation 
Intervention  Turmeric lozenge  The patients will recieve one lozenge at 8pm at night of before surgery and aother one at morning one hour before the surgery and budesonide nebulisation 10mins before intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 - 2,
Age 18-60 years,
General anaesthesia with orotracheal intubation.
 
 
ExclusionCriteria 
Details  History of preoperative URTI or LRTI,
History of reactive airway,
Pregnant women,
Anticipated difficult airway and more than one attempt at intubation,
perioperative steroid use and
surgeries on the airway including tonsilectomy, neurosurgery, emergency surgeries and surgery lasting more than 4 hours.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of Post Operative Sore Throat.  30min, 2, 6 and 24 hours post extubation. 
 
Secondary Outcome  
Outcome  TimePoints 
Severity of Post Operative Sore Throat – will be assessed using 4-point scale and Numeric rating scale
4-Point scale:
0 - no sore throat
1 - mild discomfort (complains only after questioning)
2 - moderate sore throat (complaints on their own)
3 - severe sore throat (change in voice, hoarseness and throat pain)
Numeric Rating scale : 0-10 (0 - nil, 10- possible worst pain) 
30min, 2, 6 and 24 hours post extubation. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/06/2020 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study not yet started. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Postoperative sore throat (POST) is the second most common problem found in the postoperative period following tracheal intubation, with literature reporting an incidence of 21-65%. POST occurs mainly by two mechanisms; airway instrumentation causing mucosal injury and irritating effects of a foreign object in the trachea as well as in the upper airway resulting in inflammation.

 Budesonide nebulization thought to be effective as it acts on both the upper and lower airway. Though it has not reduced the incidence of POST, it reduces the severity.Lack of local effect on the upper airway may be the reason for this finding. Lozenges used for sore throat reduces the inflammation of the upper airway by acting locally. Magnesium, zinc, strepsils lozenges were found to reduce the incidence of POST.

Studies demonstrated that the turmeric has the following properties: antioxidant, anti-inflammatory, analgesic and anti-microbial, which can possibly reduce incidence of POST. Hence We designed this prospective study to evaluate the effect of preoperative administration of Turmeric lozenges in addition with budesonide nebulization in reducing the incidence and severity of POST in patients undergoing general anaesthesia with endotracheal intubation

All patients undergoing elective surgical procedures under general anaesthesia with orotracheal intubation at MGMCRI during the study period will form the study population. 100 patients will be selected by continuous sampling after randomization and the lozenges will be kept in sealed envelope according to group allocation by anaesthesia consultant who will not take any further part in the study. In preoperative visit, patients satisfying study criteria will be allocated to one of the study groups (Group B or Group BT). The anaesthesiologist who conducts anaesthesia, blinded to the group allocation, will assess outcome measures in the postoperative period. Neither the outcome assessor nor the patients will know the content of the lozenges, and the code will not be broken until the completion of the study.

All patients will receive General anaesthesia with opioids, induction agents, inhalational anaesthetics, non-depolarizing muscles relaxants, reversal agents and analgesics according to the discretion of the attending anaesthesiologists. Intubation will be done using an Endotracheal tube with standard cuff, with cuff pressure kept at 25cm H2O throughout the surgery. Anaesthesiologists experience in years, CL grading and airway injuries during intubation will be noted. If more than one attempt required for intubation, that patient will be excluded from the study. After standard extubation criteria, patients will be extubated. The incidence of POST will be assessed by asking the presence or absence of soreness in the throat. The severity of POST will be graded on a 4-point scale . The findings will be recorded and analysed.

 
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