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CTRI Number  CTRI/2024/03/063919 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 08/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical study to compare the effectiveness of reducing post operative sore throat in tonsillectomy following dexmedetomidine intraoral spray versus ketamine intraoral spray 
Scientific Title of Study   A comparative study to evaluate the attenuation of post operative sore throat in tonsillectomy following dexmedetomidine intraoral spray versus ketamine intraoral spray: A clinical study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ranadhee Paul 
Designation  Assistant Professor, Department Of Anaesthesiology 
Affiliation  Silchar Medical College And Hospital 
Address  Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar , Assam

Cachar
ASSAM
788014
India 
Phone  7002334288  
Fax    
Email  binoy.bihari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranadhee Paul 
Designation  Assistant Professor, Department Of Anaesthesiology 
Affiliation  Silchar Medical College And Hospital 
Address  Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar, Assam

Cachar
ASSAM
788014
India 
Phone  7002334288  
Fax    
Email  binoy.bihari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranadhee Paul 
Designation  Assistant Professor, Department Of Anaesthesiology 
Affiliation  Silchar Medical College And Hospital 
Address  Department Of Anaesthesiology, Silchar Medical College And Hospital, P.O. Ghungoor, Silchar, Cachar, Assam

Cachar
ASSAM
788014
India 
Phone  7002334288  
Fax    
Email  binoy.bihari@gmail.com  
 
Source of Monetary or Material Support  
Silchar Medical College And Hospital,Silchar, PIN 788014, Cachar, Assam 
 
Primary Sponsor  
Name  Dr Ranadhee Paul 
Address  Department Of Anaesthesiology,Silchar Medical College And Hospital, P.O. Ghungoor, Silchar,Cachar,Assam, PIN 788014 
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 Ranadhee Paul  Silchar Medical College And Hospital  Department Of Anaesthesiology, SMCH, Silchar, Cachar, Assam
Cachar
ASSAM 
7002334288

binoy.bihari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Silchar Medical College And Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine intraoral spray  Dexmedetomidine intraoral spray(2mcg/kg) is given 2 minutes before intubation under direct laryngoscopy. 
Comparator Agent  Ketamine intraoral spray  Ketamine intraoral spray(25mg diluted in 2 cc saline) is given 2 minutes before intubation under direct laryngoscopy.  
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1.Only ASA I and II without any anticipated difficult airway (MPS -I & II) will be included .
2.Patients between age 12-30 years
3.Patients of both sexes
4.Patients scheduled for elective tonsillectomy under general anaesthesia
 
 
ExclusionCriteria 
Details  1.Refusal to valid informed consent.
2.History of allergy to the study drugs.
3. Patients with Cardiovascular, respiratory, renal , hepatic or neuromuscular diseases.
4. Patients with a history of preoperative sore throat, asthma, respiratory tract infection,consumption of analgesic in preoperative period, operating time more than 90 minutes, and requirement of more than one attempt for passage of endotracheal tube.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To determine whether Dexmedetomidine or Ketamine intraoral spray is more effective in attenuating the post-operative sore throat in tonsillectomy.  Comparing the time required for attenuation of sore throat in the two groups of participants at 0 hour, 2 hours, 6 hours 12 hours 18 hours and 24 hours post operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate any adverse effects of the drugs used i.e. Dexmedetomidine & Ketamine intraoral spray.  To evaluate adverse effects of the drugs at 0 hour, 2 hours, 6 hours, 12 hours, 18 hours, 24 hours post operatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 4 
Date of First Enrollment (India)   07/04/2024 
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="0"
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  

Tracheal or nasal intubation for general anesthesia causes airway mucosa trauma resulting in postoperative sore throat (POST), hoarseness, and cough . POST is a minor and common problem in patients undergoing endotracheal intubation , which commonly occurs 12 to 24 hours after the operation. Despite the mildness of symptoms, POST is one of the major cause of post operative dissatisfaction after surgery . In most cases, POST heals after surgery without specific treatment. Moderate to severe POSTS with dysphagia and pain can be treated with pharmacological agents.

Ketamine, a dissociative anesthetic agent, is the most potent of NMDA antagonists. Ketamine interacts noncompetitively with the NMDA receptors, suppresses the NMDA receptor mediated central sensitization, and potentially decreases postoperative pain

Dexmedetomidine is an alpha2 adrenergic agonists which have sedative, hypnotic  ,anxiolytic, analgesic, and sympatholytic effects. The analgesic effect of dexmedetomidine is mediated through stimulation of alpha 2c and alpha 2a receptors in the dorsal horn directly suppressing pain transmission by reducing the release of pronociceptive transmitters, substance P and glutamate and hyperpolarization of interneurons.

Therefore, this study attempted primarily to shed light upon the efficacy of dexmedetomidine intraoral spray versus ketamine intraoral spray on reducing postoperative sore throat  after tonsillectomy.

 
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