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CTRI Number  CTRI/2025/04/085238 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 21/04/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Role of magnesium sulphate and vitamin C in prevention of sore throat following endotracheal intubation  
Scientific Title of Study   Efficacy of intraoperative magnesium sulphate and vitamin C in prevention of postoperative sore throat following endotracheal intubation  
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 Rajmala Jaiswal  
Designation  Senior Professor  
Affiliation  Pt BD Sharma University of Health Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  8222897449  
Fax    
Email  Para3007@rediff.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanka Aggarwal 
Designation  Senior Resident  
Affiliation  Pt BD Sharma University of Health Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  08607920759  
Fax    
Email  aggarwal.priyanka93@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanka Aggarwal 
Designation  Senior Resident  
Affiliation  Pt BD Sharma University of Health Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care PGIMS Rohtak

Rohtak
HARYANA
124001
India 
Phone  08607920759  
Fax    
Email  aggarwal.priyanka93@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care PGIMS Rohtak, Haryana, India, 124001  
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care PGIMS Rohtak  
Address  Department of Anaesthesiology and Critical Care, PT BD Sharma PGIMS Rohtak,124001, haryana 
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 Priyanka Aggarwal   Pt BD Sharma University of Health Sciences PGIMS Rohtak   Department of Anaesthesiology and Critical Care PGIMS Rohtak, Haryana
Rohtak
HARYANA 		 08607920759

aggarwal.priyanka93@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Pt BD Sharma University of Health Sciences PGIMS Rohtak   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H664||Suppurative otitis media, unspecified, (2) ICD-10 Condition: D34||Benign neoplasm of thyroid gland, (3) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (4) ICD-10 Condition: S529||Unspecified fracture of forearm, (5) ICD-10 Condition: K469||Unspecified abdominal hernia without obstruction or gangrene, (6) ICD-10 Condition: T148||Other injury of unspecified body region,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Magnesium sulphate and vitamin C  1gram of magnesium sulphate intravenous after induction of anaesthesia over 30 minutes and 2 grams of vitamin C intravenous after induction of anaesthesia over 30 minutes  
Comparator Agent  Normal saline  100 ml normal saline intravenous after induction of anaesthesia over 30 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients in age group between 18 to 60 years of either sex, belonging to American
Society of Anaesthesiologists (ASA) physical status I and II will be included in the study who will undergo general anaesthesia with placement of endotracheal tube. 
 
ExclusionCriteria 
Details  Unwillingness of patient, history of preoperative sore throat,any recent use of anti-inflammatory drugs, major hepatic,renal, cardiovascular,respiratory and neuromuscular disease, duration of surgery more than 3 hours, attempts of endotracheal intubation more than one, pregnant and lactating women, previous history of allergy to study drug, anticipated difficult airway  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Severity of postoperative sore throat   At 0 h, 6 hours, 12 hours and 24 hours postoperatively  
 
Secondary Outcome  
Outcome  TimePoints 
Side effects if any  At 0, 6 hours, 12 hours and 24 hours postoperatively  
 
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 4 
Date of First Enrollment (India)   25/05/2025 
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="1"
Months="1"
Days="1" 
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   All patients will be subjected to the pre-anaesthetic assessment prior to enrollment in the study. Their detailed medical and surgical history will be taken along with any previous anaesthetic exposure with its outcome. A thorough airway, systemic examination will also be done. The routine investigations will be done for all patients. All patients scheduled for surgery will be kept fasting for at least 6 hours prior to surgery. 
Randomization will be done by computer generated random numbers. Neither the investigators not the patients will know about the study drug and the code will be broken after the completion of study. The selected patients will be randomly allocated to one of the following three groups:
Group I (n=30)- patients receiving intravenous magnesium sulphate
Group II (n=30)- patients receiving intravenous vitamin C
Group III (n=30)- patients receiving normal saline 
After informed consent, patient will be transferred to operating room, standard monitors (ECG, NIBP, SpO2) will be attached. After induction of anaesthesia as per standard protocol, patients will be given one of study drug ( magnesium sulfate, vitamin C, Normal saline) by the resident who is not further involved in study. Magnesium sulfate 1 gram intravenous, vitamin C 2 gram intravenous and 100 ml normal saline over 30 minutes after induction. At the end of surgery injection paracetamol 1g intravenous will be given to all patients . After completion of surgery and emergence from general anaesthesia, patients will be transferred to post anesthesia care unit (PACU). Once in PACU, patients will be assessed for postoperative sore throat using a standardized scale. The severity of POST will be graded on a 4- point scale ranging from 0-3; 0 being no sore throat, 1 being mild sore throat ( complain only upon questioning), 2 being moderate sore throat ( complain on his/her own), 3 being severe sore throat ( change in voice , hoarseness, throat pain). This evaluation will be performed at 0 h, 6 hours, 12 hours and 24 hours postoperatively. Any side effects occuring will be noted.
 
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