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CTRI Number  CTRI/2025/06/088581 [Registered on: 11/06/2025] Trial Registered Prospectively
Last Modified On: 06/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study on comparing efficacy of nebulized ketamine, betamethasone, and lignocaine for reducing postoperative sore throat, cough, and hoarseness of voice in elective surgery patients under general anaesthesia. 
Scientific Title of Study   comparative efficacy of nebulized ketamine, betamethasone, and lignocaine for mitigating postoperative sore throat, cough, and hoarseness of voice in elective surgery patients under general anaesthesia - a double blind randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAZREEN BANU J 
Designation  JUNIOR RESIDENT 
Affiliation  All India Institute Of Medical Sciences, Nagpur 
Address  Department of Anaesthesia, AIIMS NAGPUR, NAGPUR, MAHARASHTRA
Department of Anaesthesia , AIIMS Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441108
India 
Phone  6374446528  
Fax    
Email  nazreennishahussain@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR. AVINASH PRAKASH 
Designation  ASSOCIATE PROFESSOR 
Affiliation  All India Institute Of Medical Sciences, Nagpur 
Address  Department of Anaesthesia, AIIMS NAGPUR, NAGPUR, MAHARASHTRA
Department of Anaesthesia , AIIMS Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441108
India 
Phone  9999596845  
Fax    
Email  dravinash@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query
 
Name  NAZREEN BANU J 
Designation  JUNIOR RESIDENT 
Affiliation  All India Institute Of Medical Sciences, Nagpur 
Address  Department of Anaesthesia , AIIMS NAGPUR, NAGPUR, MAHARASHTRA
Department of Anaesthesia , AIIMS Nagpur, Maharashtra
Nagpur
MAHARASHTRA
441108
India 
Phone  6374446528  
Fax    
Email  nazreennishahussain@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Dahegaon, MIHAN, Nagpur. PINCODE:441108 
 
Primary Sponsor  
Name  DR NAZREEN BANU J 
Address  DEPARTMENT OF ANAESTHESIA, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MIHAN, DAHEGAON, NAGPUR, MAHARASHTRA 
Type of Sponsor  Other [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 NAZREEN BANU J  ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NAGPUR  DEPARTMENT OF ANAESTHESIA, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, MIHAN, DAHEGAON, NAGPUR, MAHARASHTRA
Nagpur
MAHARASHTRA 
6374446528

nazreennishahussain@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, (2) ICD-10 Condition: J00-J06||Acute upper respiratory infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NEBULIZATION WITH BETAMETHASONE  ONE GROUP WILL BE NEBULIZED WITH BETAMETHASONE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA 
Intervention  NEBULIZATION WITH KETAMINE  ONE GROUP WILL BE GIVEN NEBULIZATION WITH KETAMINE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA 
Intervention  NEBULIZATION WITH LIGNOCAINE  ONE GROUP WILL BE GIVEN NEBULIZATION WITH LIGNOCAINE FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA 
Comparator Agent  NEBULIZATION WITH NORMAL SALINE  ONE GROUP WILL BE NEBULIZED WITH NORMAL SALINE -PLACEBO AGENT FOR MITIGATING POST OPERATIVE HOARSENESS, COUGH AND SORE THROAT IN ELECTIVE SURGERY PATIENTS UNDER GENERAL ANAESTHESIA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.All adult patients aged between 18 to 65 years.
2.Patients with American Society of Anaesthesiologists (ASA) physical status classes I or II.
3.Patients scheduled for elective surgery requiring general anaesthesia with endotracheal intubation.
4.Patients who provided informed consent to participate in the study
 
 
ExclusionCriteria 
Details  1.All adult patients aged below 18 and above 65 years.
2.Patients with American Society of Anaesthesiologists (ASA) physical status above classes II.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of the incidence of postoperative sore throat, cough, and hoarseness of voice within the first 24 hours following surgery.
2.Comparison of the severity of postoperative sore throat, cough, and hoarseness of voice among patients receiving nebulised ketamine, betamethasone, or lignocaine
3.Haemodynamic variables (HR, BP, SpO2) will be monitored, compared before nebulisation before intubation and post extubation 
18 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.Assessment of the duration (in hours) of postoperative sore throat, cough, and hoarseness of voice among patients in each intervention group.
2.Identification and documentation of any adverse effects related to the administration of nebulised ketamine, betamethasone, or lignocaine.
3.Assessment of patient satisfaction with postoperative throat symptoms and overall comfort using a standardized satisfaction survey or questionnaire.
4.Comparison of patient satisfaction levels between the nebulised ketamine, betamethasone, and lignocaine intervention groups to identify differences in perceived effectiveness and comfort.
 
18 months 
 
Target Sample Size   Total Sample Size="160"
Sample Size from India="160" 
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 2/ Phase 3 
Date of First Enrollment (India)   17/06/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  17/06/2025 
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  
Postoperative sore throat (POST) is a common occurrence following general anaesthesia with endotracheal intubation although clinicians often regard it as a minor complication. The incidence of POST is estimated to be 21%–65% in different studies. POST although a self-limiting complication following general anaesthesia with endotracheal intubation, it continues to be an important concern for surgical patients. As perioperative physicians, we are entrusted with the deeds of decreasing the sufferings of surgical patients. When reviewing the literature for the prevention of POST, some non-pharmacological and pharmacological interventions have been tried with varying success rates. Nebulization is inexpensive, quick, convenient, and easy to administer also, which made this, the route of choice. In our study, we compared the effectiveness of ketamine and magnesium sulphate nebulization on POST .
The following factors influences the incidence of post-operative sore throat, which includes Experience of anaesthetist, adequate relaxation of the patient, careful insertion technique, soft suction catheters, smaller tracheal tubes, minimal cuff-tracheal contact area, monitoring and adjustment of intracuff pressure and avoidance of local anaesthetic /steroid lubricants. Various methods to alleviate postoperative sore throat has been reported in the literature. There are variable causes that can aggravate sore throat such as patient related factors, type of anaesthesia and type of surgery. Steroids are commonly used intraoperatively to reduce airway oedema and inflammation. Ketamine gargling has been used for sore throat but due to risk of aspiration, palatability limits its usage. Lignocaine jelly applied over tracheal tube cuff may reduce sore throat but because of inaccuracy of instilled drug and short duration of action some additional management has to follow for postoperative sore throat. Nebulization of lignocaine and ketamine prior to general anaesthesia confers good tube tolerability to patient as entire air passages is anaesthetized and attenuates sore throat after extubation 
Ketamine has pharmacological properties such as analgesia, anaesthesia, and sympathetic action. Some studies have been done which show that ketamine decreases tumour necrosis factor-alpha production in a lipopolysaccharide-induced rat model of sepsis, and it demonstrates a protective mechanism in lung injury by decreasing the expression of inducible nitric oxide synthase and by its anti-inflammatory properties. Studies have suggested its role in endotoxin-induced tissue injury. It has been observed that local use of this drug through the nasal, oral, and rectal routes is both effective and plausible in ant nociception and anti-inflammatory cascade. Local anaesthetic drugs act by producing a reversible block to the transmission of peripheral nerve impulses. Lignocaine is used commonly for infiltration in concentrations of 0.5%–1.0% and for peripheral nerve blocks if an intermediate duration is required. Lidocaine 2%–4% is used by many anaesthetists as a topical solution for anaesthesia of the upper airway before awake intubation.

 
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