FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/04/083842 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 30/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study Effectiveness of preinduction ketamine versus magnesium sulphate nebulization on the incidence of sore throat after general endotracheal anesthesia. 
Scientific Title of Study   Effectiveness of preinduction ketamine versus magnesium sulphate nebulization on the incidence of sore throat after general endotracheal anesthesia: A prospective randomized double blind comparative 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 Bhumireddy Anusha 
Designation  Post graduation (PG)  
Affiliation  Sri venkateswara institute of medical sciences(SVIMS) 
Address  Department of Anesthesiology,SVIMS, AlipiriRoad, Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9989067570  
Fax    
Email  anushabhumireddy100@gmail.con  
 
Details of Contact Person
Scientific Query  
Name  Dr M Madhusudan 
Designation  Professor, Department of Anesthesiology and critical care medicine, SVIMS 
Affiliation  Sri venkateswara institute of medical sciences(SVIMS) 
Address  Department of Anesthesiology,SVIMS, Alipiri road, Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9493547723  
Fax    
Email  drmadhu37@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M Madhusudan 
Designation  Professor, Department of Anesthesiology and critical care medicine, SVIMS 
Affiliation  Sri venkateswara institute of medical sciences(SVIMS) 
Address  Department of Anesthesiology,SVIMS, Alipiri road, Tirupati.

Chittoor
ANDHRA PRADESH
517501
India 
Phone  9493547723  
Fax    
Email  drmadhu37@gmail.com  
 
Source of Monetary or Material Support  
Sri venkateswara institute of medical sciences(SVIMS), Alipiri road, Tirupati, Chittoor, Andhra pradesh, India,517507. 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Bhumireddy Anusha  Sri venkateswara institute of medical sciences(SVIMS)  Department of Anesthesiology,SVIMS, AlipiriRoad, Tirupati.
Chittoor
ANDHRA PRADESH 		 9989067570

anushabhumireddy100@gmail.con 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, SVIMS, Tirupati SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES Alipiri Road SVIMS Campus Tirupati Chittoor Andhra Pradesh  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  Group Ketamine (Group K)   After thorough pre anesthetic evaluation, all study participants will be received tablet alprazolam 0.25 mg night before surgery and tablet pantop 40 mg morning on the day of surgery as a premedication. Twenty minutes prior to induction of anesthesia, all the patients will be nebulized with one of the study drugs diluted to 2ml with normal saline i.e,1ml study drug with 1ml normal saline. Group K patients will be received ketamine 50mg 
Comparator Agent  Magnesium sulphate group (Group M)  After thorough pre anesthetic evaluation, all study participants will be received tablet alprazolam 0.25 mg night before surgery and tablet pantop 40 mg morning on the day of surgery as a premedication. Twenty minutes prior to induction of anesthesia, all the patients will be nebulized with one of the study drugs diluted to 2ml with normal saline i.e,1ml study drug with 1ml normal saline Group M patients will be received magnesium sulphate 500mg 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients aged 18 to 65 years.
2)Patients with American Society of Anesthesiologists (ASA) physical status I to III
3)Patients with Mallampati grade (MPG) I to III
4)Patients scheduled to undergo elective surgery of 4 hours duration who requires general endotracheal anesthesia. 
 
ExclusionCriteria 
Details  1)Patients having history of preoperative sore throat or recent upper respiratory tract infection.
2)Patients undergoing oral surgeries, neck surgeries like thyroid surgery.
3)Patients with known allergy to study drug.
4)Hypertensive patients.
5)Patients with raised renal parameters.
6)Patients requiring more than 3 attempts at intubation.
7)Pregnant and lactating women.
8)Patients not willing to give consent. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare efficacy of ketamine nebulization versus magnesium sulphate nebulization on incidence post operative sore throat  at induction, 2 hours, 4 hours, 6 hours and 12 hours  
 
Secondary Outcome  
Outcome  TimePoints 
1.Incidence of postoperative cough and hoarseness of voice
2.Severity of postoperative sorethroat
3.Severity of postoperative cough
4.Severity of postoperative hoarseness
5.Risk of adverse effects due to study drugs 		 at 0,1,2,4,6 and 24 hours after tracheal extubation 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/04/2025 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [anushabhumireddy100@gmail.com].

  6. For how long will this data be available start date provided 16-01-2027 and end date provided 16-03-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Postoperative sore throat (POST) is a well-recognized complication which is remaining unsolved, contributing to postoperative morbidity and patient’s dissatisfaction with reported incidence of 6.6 to 90% in different studies worldwide. It also increased the duration of hospital stay, especially in a day care procedure.
Both pharmacological and non-pharmacological measures have been used for attenuating POST.
Pharmacological measures for attenuating POST includes inhalation of beclomethasone and fluticasone, gargling with azulene sulfonate, ketamine, benzadymine hydrochloride, and intra cuff administration of alkalinized lignocaine etc.
It is known that N-methyl-D-aspartate (NMDA) has a role in nociception and inflammation. NMDA receptors are found in peripheral nerves and the central nervous system. 
NMDA receptors antagonist such as magnesium sulphate, ketamine (phencyclidine derivative) has been used independently as pre operative nebulization in reducing POST.
In present study,we would like to find out the effectiveness of pre induction ketamine nebulization versus magnesium sulphate nebulization on incidence of POST.
 
Close