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CTRI Number  CTRI/2024/04/065794 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   comparing efficacy of preoperative magnesium sulphate nebulization with ketamine nebulization in reducing incidence of severity of post operative sore throat in patient undergoing surgery under general anesthesia.,  
Scientific Title of Study   To study and compare the efficacy of preoperative Magnesium Sulphate nebulization with Ketamine nebulization In reducing the incidence and severity of post-operative pharyngolaryngeal complications - A prospective triple blinded randomised controlled 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  Shivakumar Kala Vaishnav Krishna 
Designation  Junior resident 
Affiliation  Dr Rajendra Prasad Governent Medical College Tanda,Kangra. 
Address  Dr Rajendra Prasad Governent Medical College Tanda,Kangra.

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7411276092  
Fax    
Email  vaishnavrgpmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhanu Gupta 
Designation  Assistant Professor  
Affiliation  Dr Rajendra Prasad Governent Medical College Tanda,Kangra. 
Address  Dr Rajendra Prasad Governent Medical College Tanda,Kangra.

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418016807  
Fax    
Email  bhanurpgmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  shivakumar kala vaishnav krishna 
Designation  Junior resident 
Affiliation  Dr Rajendra Prasad Governent Medical College Tanda,Kangra. 
Address  Dr Rajendra Prasad Governent Medical College Tanda,Kangra.

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7411276092  
Fax    
Email  vaishnavrgpmc@gmail.com  
 
Source of Monetary or Material Support  
N/A 
 
Primary Sponsor  
Name  dr vaishnav 
Address  Room no 101,1st Floor Dr Rajendra Prasad Governent Medical College Tanda,Kangra.176002 
Type of Sponsor  Government medical college 
 
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 Vaishnav  Dr Rajendra Prasad Governent Medical College Tanda,Kangra.  Room No 304, Preoperative Room,3rd Floor, OT Complex.
Kangra
HIMACHAL PRADESH 
7411276092

vaishnavrgpmc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr RPGMC KANGRA at Tanda   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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparing postoperative sorethorat after nebulization with Magnesium Sulphate and Ketamine.  Comparing Post operative Sorethroat at 2,6,12,24,48h. 
Intervention  Patients are randomly selected and Nebulized with magnesium sulphate 250mg and ketamine 50mg for 15 mins before surgery. Patients are then followed up for developing pharnygolaryngeal complications total duration of this study will be 12months  Nebulization done with Magnesium sulphate and ketamine before surgery to know which drug is more effective in reducing incidence of pharnygolaryngeal complications total duration of study will be 12months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Males and females between the age group 18-60 years.
2. ASA class I-II.
3. Body mass index(BMI) 18.5-29.9.
4. Undergoing surgeries requiring general anaesthesia with cuffed ETT of duration 60-120 minutes. 
 
ExclusionCriteria 
Details  1. Patient’s refusal participation in study.
2. Haemodynamically unstable patients.
3. History of hypertension, asthma, chronic obstructive pulmonary disease(COPD), cardiovascular disease, renal disease, diabetes mellitus, cerebrovascular disease.
4. Patients having known hypersensitivity to drugs under consideration.
5. Patient with three or more attempts at laryngoscopy or bougie for intubation.
6. Patients who sustained trauma while intubation or nasogastric tube insertion as evidenced by blood on cuff after extubation or blood stained secretions while suctioning before extubation.
7. Patient suffering from active or recent (past 6 weeks) upper airway tract infection (preoperative sore throat, cough) and edema/inflammation noticed during laryngoscopy.
8. Surgery requiring placement of nasogastric tube intraopeartively.
9. Patients already on analgesics or steroids (systemic or inhaled). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
PRIMARY OBJECTIVES
1. To Evaluate & compare the effectiveness of nebulised Magnesium sulfate & ketamine in:
a. Extubation Quality using 5 point extubation quality score.
b. Post extubation airway related adverse effects like cough (POC), sore throat (POST) & hoarseness (POH).
SECONDARY OBJECTIVES
1. To access the haemodynamic parameter during surgery & extubation.
2. To access the airway dynamics during surgery & extubation.
3. To study side effect of study drugs if any.
4. Patient satisfaction score. 
2,4,6,12,24,48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
SECONDARY OBJECTIVES
1. To access the haemodynamic parameter during surgery and extubation.
2. To access the airway dynamics during surgery and extubation.
3. To study side effect of study drugs if any.
4. Patient satisfaction score.
 
2,4,6,12,24,48hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   26/04/2024 
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="1"
Months="0"
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Vaishnavrgpmc@gmail.com).

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   We will be nebulizing patients with magnesium sulfate 250mg and ketamine 50mg over 15 minutes and then follow up patients for developing pharnygolaryngeal complications.  
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