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CTRI Number  CTRI/2024/09/073464 [Registered on: 05/09/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of preoperative tramadol gargle on postoperative throat pain in middle ear surgeries under general anaesthesia 
Scientific Title of Study   Effect of preoperative tramadol gargle on postoperative sore throat in middle ear surgeries under general anaesthesia with endotracheal intubation 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha R 
Designation  junior resident 
Affiliation  ESICMC AND PGIMSR RAJAJINAGAR BENGALURU 
Address  Department of Anaesthesiology ESIMC AND PGIMSR Rajajinagar Bangalore.

Bangalore
KARNATAKA
560010
India 
Phone  7204045926  
Fax    
Email  neharamaprasad@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G B Sumalatha 
Designation  Professor 
Affiliation  ESICMC AND PGIMSR RAJAJINAGAR BENGALURU 
Address  2nd floor OT complex, Department of Anaesthesiology, ESICMC AND PGIMSR, Rajajinagar, Bangalore.

Bangalore
KARNATAKA
560010
India 
Phone  9538301444  
Fax    
Email  gbsumaravi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G B Sumalatha 
Designation  Professor 
Affiliation  ESICMC AND PGIMSR RAJAJINAGAR BENGALURU 
Address  2nd floor OT complex, Department of Anaesthesiology, ESICMC AND PGIMSR, Rajajinagar, Bangalore.

Bangalore
KARNATAKA
560010
India 
Phone  9538301444  
Fax    
Email  gbsumaravi@gmail.com  
 
Source of Monetary or Material Support  
ESICMC AND PGIMSR, Rajajinagar, Bangalore, Karnataka, India 560010. 
 
Primary Sponsor  
Name  NEHA R 
Address  PG hostel ESIMC AND PGIMSR Rajajinagar Bengaluru 560010 
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 Neha R  ESICMC AND PGIMSR   2nd floor OT complex, Department of Anaesthesiology, ESICMC AND PGIMSR, Rajajinagar, Bangalore- 560010
Bangalore
KARNATAKA 		 7204045926

neharamaprasad@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ESICMC AND PGIMSR RAJAJINAGAR BENGALURU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H661||Chronic tubotympanic suppurative otitis media, (2) ICD-10 Condition: H662||Chronic atticoantral suppurative otitis media, (3) ICD-10 Condition: H742||Discontinuity and dislocation of ear ossicles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Effect of preoperative normal saline gargle on postoperative sore throat  Comparison between oral tramadol(50mg tramadol in 29ml normal saline) gargle and normal saline(30ml) gargle given 5 minutes prior to induction of general anaesthesia for postoperative sore throat at 0, 2, 6, 12 and 24 hours in middle ear surgeries with endotracheal intubation 
Intervention  Effect of preoperative tramadol gargle on postoperative sore throat  Patients randomised into 2 groups by a computer generated random number table. Group A- oral tramadol(50mg tramadol in 29ml normal saline) gargle and group B- normal saline gargle given 5 minutes prior to induction of general anaesthesia for postoperative sore throat in 24 hours at 0, 2, 6, 12 and 24 hours in middle ear surgeries with endotracheal intubation 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient willing to provide informed written consent
ASA 1 and 2
Patients undergoing elective middle ear surgery under general anaesthesia
Duration of surgery less than 4 hours 
 
ExclusionCriteria 
Details  1. Patients with history of preoperative sore-throat.
2. History or anticipated difficult intubation.
3. Patients requiring more than one attempt at intubation.
4. History of tramadol/opioid allergy or hypersensitivity.
5. Patients requiring the insertion of a nasogastric tube.
6. History of asthma, chronic obstructive pulmonary disease.
7. Recent upper respiratory tract infection (within 15 days).
8. Patient with history of smoking.
9. Patients on steroid therapy.
10. History of seizure disorder.
11. Patients on antidepressants. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To study the incidence and severity of sore throat up to 24 hours postoperatively  To study the incidence and severity at 0, 2, 6, 12, 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the following at 0, 2h, 6h, 12h and 24h postoperatively:
- Cough
- Hoarseness of voice
 		 0, 2, 6, 12, 24 hours 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 3 
Date of First Enrollment (India)   20/09/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This study is designed to study the effect of preoperative Tramadol gargle on postoperative sore throat in patients scheduled for elective middle ear surgeries under general anaesthesia with oral endotracheal intubation. Post-operative sore throat (POAT) is rated to be the 8th most undesirable outcome in the postoperative period with an incidence ranging from 14.4-50% after tracheal intubation and 5.8-34% after laryngeal mask airway insertion. The etiology of sore throat is thought to involve mucosal dehydration, trauma from instrumentation and intubation, and mucosal erosion caused by endotracheal tube cuff. Potential risk reduction interventions for POST include smaller sized tube size, limiting intra-cuff pressure, video laryngoscopy, gentle airway instrumentation, extubation after full deflation of cuff, benzydamine hydrochloride, aspirin (NSAIDs), ketamine, magnesium sulphate (NMDA receptor antagonists) and tramadol. Tramadol is a centrally acting analgesic with μ receptor affinity, which inhibits norepinephrine and 5-hydroxytryptamine re-uptake with modulatory effects on voltage gated sodium ion channels, thus exerting a local anaesthetic effect. Tramadol is shown to reduce pain on peritonsillar injection, topical use over tonsillar fossa and to attenuate sore throat when used in gargle form.

 
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