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CTRI Number  CTRI/2026/02/103450 [Registered on: 09/02/2026] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Postoperative Sore Throat in Head, Neck and Face Surgery Patients: Comparative Effectiveness Of Ketamine, Dexmedetomidine and Dexamethasone Soaked Pharyngeal Packs  
Scientific Title of Study   A COMPARATIVE STUDY BETWEEN KETAMINE VERSUS DEXMEDETOMIDINE VERSUS DEXAMETHASONE SOAKED PHARYNGEAL PACKS IN REDUCING POSTOPERATIVE SORE THROAT AFTER HEAD, NECK AND FACE SURGERIES 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DIVYA SINGH 
Designation  JUNIOR RESIDENT-2 
Affiliation  GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL  
Address  DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA
DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA
Mumbai
MAHARASHTRA
400008
India 
Phone  7985435873  
Fax    
Email  divya.disi.jnv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SUKRITI ATRAM 
Designation  ASSOCIATE PROFESSOR  
Affiliation  GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL  
Address  DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL
DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL
Mumbai
MAHARASHTRA
400008
India 
Phone  9004083034  
Fax    
Email  sukritiatram@yahoo.in  
 
Details of Contact Person
Public Query  
Name  DR SUKRITI ATRAM 
Designation  ASSOCIATE PROFESSOR  
Affiliation  GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL  
Address  DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL
DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL
Mumbai
MAHARASHTRA
400008
India 
Phone  9004083034  
Fax    
Email  sukritiatram@yahoo.in  
 
Source of Monetary or Material Support  
DEPARTMENT OF ANESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL, BYCULLA, MUMBAI, MAHARASHTRA, 400008 
 
Primary Sponsor  
Name  DIVYA SINGH  
Address  DEPARTMENT OF ANAESTHESIOLOGY, GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL BYCULLA, MUMBAI, MAHARASHTRA, 400008 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DIVYA SINGH   GRANT GOVERNMENT MEDICAL COLLEGE AND SIR JJ HOSPITAL   DEPARTMENT OF ANESTHESIOLOGY, JJ MARG, BYCULLA, 400008
Mumbai
MAHARASHTRA 		 7985435873

divya.disi.jnv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE OF ETHICS COMMITEE, GRANT GOVERNMENT MEDICAL COLLEGE, MUMBAI 400008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXAMETHASONE  IT IS A CORTICOSTEROID WHICH FAVOURS DECREASED PRODUCTION OF INFLAMMATORY MEDIATORS, INHIBITION OF PHOSPHOLIPASE A2 AND CHANGES IN CELL FUNCTION INDUCED BY GLUCOCORTICOID RECEPTOR ACTIVATION AMOUNTING TO ITS ANTIINFLAMMATORY ACTION 
Intervention  DEXMEDETOMIDINE  THIS DRUG IS AN ALPHA-2 ADRENERGIC AGONIST AND THUS HAS SYMPATHOLYTIC EFFECT. PRESYNAPTIC ACTIVATION OF THESE RECEPTORS BY DEXMEDETOMIDINE INHIBITS THE RELEASE OF NOREPINEPHRINE AND TERMINATES PROPAGATION OF PAIN SIGNALS. POSTSYNAPTIC ACTIVATION OF ALPHA ADRENORECEPTORS IN CENTRAL NERVOUS SYSTEM INHIBITS SYMPATHETIC ACTIVITY WHICH DECREASES BLOOD PRESSURE AND HEART RATE. ALSO, THIS DRUG INHIBITS LOCUS COERULEUS NUCLEUS PRESENT IN PONS AND PRODUCES SEDATIVE EFFECTS 
Intervention  KETAMINE  THIS DRUG PRODUCES "DISSOCIATIVE ANAESTHESIA" BY ACTING BETWEEN THE THALAMOCORTICAL AND LIMBIC SYSTEMS AND ALSO SUPPRESSES NEUTROPHIL-MEDIATED INFLAMMATORY RESPONSES, IMPROVES BLOOD FLOW, THUS REDUCING DISCOMFORT DUE TO POSTOPERATIVE SORE THROAT 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  PATIENTS POSTED FOR HEAD, NECK AND FACE SURGERIES UNDER GENERAL ANESTHESIA WITH ENDOTRACHEAL INTUBATION.
PATIENTS WHO ARE CLASSIFIED WITH ASA GRADE I OR II.
PATINETS WHO ARE CLASSIFIED WITH MALLAMPATI SCORE 1 OR 2. 
 
ExclusionCriteria 
Details  PATIENTS WITH HISTORY OF RECENT AND/OR ACTIVE UPPER RESPIRATORY TRACT ILLNESS.
PATIENTS WHO ARE CHRONIC SMOKERS.
PATIENTS WITH ANTICIPATED DIFFICULT AIRWAY.
PATIENTS WITH HISTORY OF PREOPERATIVE SORE THROAT.
PATIENTS WITH KNOWN ALLERGY TO STUDY DRUG.
PREOPERATIVE USE OF ANALGESIC DRUGS, LIKE NSAIDS OR OPIOIDS OR STEROIDS. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
INCIDENCE AND/OR SEVERITY OF POSTOPERATIVE SORE THROAT AMONG THREE DRUGS GROUPS NAMELY KETAMINE, DEXMEDETOMIDINE AND DEXAMETHESONE SOAKED PHARYNGEAL PACKS.   BASELINE, AFTER INDUCTION, JUST BEFORE INTUBATION, AFTER PHARYNGEAL PACKING, POST EXTUBATION IMMEDIATELY, 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS, 24 HOURS. 
 
Secondary Outcome  
Outcome  TimePoints 
ASSESSING THE PATIENTS FOR INTENSITY OF SORE THROAT, HEMODYNAMIC CHANGES (FOR EXAMPLE: HEART RATE, BLOOD PRESSURE)  BASELINE, AFTER INDUCTION, JUST BEFORE INTUBATION, AFTER PHARYNGEAL PACKING, POST EXTUBATION IMMEDIATELY, 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS, 24 HOURS. 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   10/02/2026 
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="8"
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 PROSPECTIVE COMPARATIVE STUDY IS DESIGNED TO COMPARE THE EFFECTIVENESS OF PHARYNGEAL PACKS SOAKED WITH KETAMINE (1ML OF 50MG/ML + 19 ML NORMAL SALINE), DEXMEDETOMIDINE (75 MCG + 20 ML NORMAL SALINE) AND DEXAMETHASONE (8 MG IN 18 ML NORMAL SALINE)  AFTER ENDOTRACHEAL INTUBATION AND KEPT THROUGHOUT SURGERY FOLLOWED BY REMOVAL OF PACK BEFORE EXTUBATION, IN REDUCING THE INTENSITY OF POSTOPERATIVE SORE THROAT IN PATIENTS UNDERGOING GENERAL ANESTHESIA.
A TOTAL OF 102 PATIENTS WITH ASA GRADE I OR II, AGED 18-60 YEARS AND MALLAMPATI SCORE 1 OR 2 WILL BE RANDOMLY ASSIGNED TO THREE GROUPS. INTENSITY OF POSTOPERATIVE SORE THROAT WILL BE ASSESSED IMMEDIATELY AFTER EXTUBATION AND THEN 2 HOURS, 4 HOURS, 8 HOURS, 12 HOURS AND 24 HOURS POST EXTUBATION USING STANDARDISED GRADING CRITERIA. HEMODYNAMIC VARIABLES SUCH AS HEART RATE, BLOOD PRESSURE AND ANY DRUG RELATED ADVERSE EVENT WILL ALSO BE MONITORED AND DOCUMENTED.
THIS STUDY IS ANTICIPATED TO DEMONSTRATE THAT ALL THE THREE DRUGS; KETAMINE, DEXMEDETOMIDINE AND DEXAMETHASONE ARE EFFECTIVE IN REDUCING POSTOPERATIVE SORE THROAT WITH EITHER SIMILIAR EFFICACY ORA STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE THREE AGENTS. THE FINDINGS MAY HELP DETERMINE A SAFE AND EFFECTIVE INTERVENTION FOR MINIMIZING POST INTUBATION AIRWAY RELATED MORBIDITY.
 
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