| 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 |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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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 |
|
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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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z409||Encounter for prophylactic surgery, unspecified, |
|
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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.
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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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. |
|
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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)?
|
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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. |