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CTRI Number  CTRI/2024/04/065024 [Registered on: 01/04/2024] Trial Registered Prospectively
Last Modified On: 30/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Medicine to use to prevent pain in the throat after general anaesthesia. 
Scientific Title of Study   Comparison of efficacy of pre-operative nebulized magnesium sulphate versus lidocaine on the prevention of post-intubation sore throat: a randomised control 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. E. R. Revaanth 
Designation  Post Graduate Student. 
Affiliation  Bangalore Medical College and Research Institute. 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9080537427  
Fax    
Email  revaanth1996@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR. Swathi N 
Designation  Assistant Professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9972454989  
Fax    
Email  swathisaggi@gmail.com  
 
Details of Contact Person
Public Query  
Name  DR. Ramachandraiah R 
Designation  Professor 
Affiliation  Bangalore Medical College and Research Institute. 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.

Bangalore
KARNATAKA
560002
India 
Phone  9972454989  
Fax    
Email  ramachandraiah090@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical College and Research Institute. 
 
Primary Sponsor  
Name  DR E R Revaanth 
Address  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.  
Type of Sponsor  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 E R Revaanth  Bangalore Medical College and Research Institute.  3rd floor, MPB building, Department of Anaesthesiology, Victoria hospital, Bangalore Medical College and Research Institute, kR road, Fort, Bengaluru.
Bangalore
KARNATAKA 		 9080537427

revaanth1996@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bangalore Medical College and Research Institute.  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 
Comparator Agent  Lignocaine 2% 100 mg   Patients nebulised with lignocaine 2% (5 ml) before induction of general anaesthesia 
Intervention  Magnesium sulphate 250 mg  Patients nebulised with magnesium sulphate 2.5 ml plus sterile water 2.5 ml before induction of general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patient willing to give informed written consent
2 Adult normotensive patients aged between 18 to 60 years posted for surgery
3 American society of Anaesthesiology (ASA) grade 1 or 2
 
 
ExclusionCriteria 
Details  1 Patients scheduled for surgeries under General anaesthesia more than 4hrs duration
2 Patients with neuromuscular disease, cardio vascular, respiratory, renal and hepatic derangement
3 Patients has allergy or hypersensitivity to drugs
4 Attempt of nasogastric tube pre-operatively and intra-operatively
5 Patients undergoing head and neck surgery, laparoscopic surgery, prone positing during surgery.
6. Patient with incidence of post laryngospasm.
7 Patient with anticipated or attempted difficult intubation.
8 Patient intubated with any maneuver other than laryngoscope eg; i-gel, laryngeal mask airway or fiber-optic guided.
9 Patient with history of pre-operative sore throat, using steroid, or analgesic in last 48h
10 Pregnant women, psychiatric illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the Post-operative Sore throat after Extubation at rest and on swallowing  IMMEDIATE POSTOP 4 hours , 8 hours, 12 hours, 24 hours and 48 hours 
 
Secondary Outcome  
Outcome  TimePoints 
To look for other side effects like nausea vomiting sedation cough laryngospasam hoarseness of voice dysphagia dysphonia

To assess hemodynamic changes in response to laryngoscopy and intubation
 		 IMMEDIATE POSTOP 4 hours , 8 hours, 12 hours, 24 hours and 48 hours 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   08/04/2024 
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="6"
Days="30" 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 (Others) -  .....

  6. For how long will this data be available start date provided 27-03-2024 and end date provided 27-03-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

   All patients will be kept fasting overnight and pre medicated with oral tablet alprazolam 0.5mg and tablet ranitidine 150mg on night before surgery.

  In the preparation room, intravenous line will be secured and standard monitors will be connected (Electrocardiogram – ECG, non-invasive blood pressure and pulse oximetry) and baseline parameters such as heart rate (HR), systolic & diastolic blood pressure (BP) and peripheral oxygen saturation (spo2) will be noted.

Before induction of general anesthesia, 80 patients will be divided randomly by computer-generated randomization table into 2 groups each was 40.www.randomization.com.

Patients will be nebulized in sitting position through piston type compressor nebulizer for 15 min, 30 mins prior to the induction of general anesthesia.

·       Group (M) (n=40): patients nebulized with magnesium sulfate 250mg (2.5ml) plus sterile water (2.5ml). Total volume 5ml.

·       Group (N) (n=40): patients nebulized with lidocaine 2% 100mg (5ml)

Total volume 5ml.

The drugs will be loaded by nursing staff and will be blinded to the investigator and patient.

After nebulization, the patient will be transferred to the operating room, standard monitors will be applied (ECG, noninvasive blood pressure and pulse oximetry). Patient will be pre-oxygenated with 5 L/min oxygen (O2) 100% for 3 minutes. Induction will be done with fentanyl 2μg/kg and propofol 2mg/kg. Endotracheal intubation will be facilitated by Vecuronium 0.1 mg/kg. Smooth laryngoscopy and intubation will be performed by an experienced anesthesiologist using cuffed soft seal sterile polyvinyl chloride tracheal tube of 7-mm inner diameter for female and 8 mm for male patients. The cuff will be inflated with air and the pressure in the cuff was maintained between 20 and 22 cm H2O using a pressure manometer. To prevent the mucosal dryness we will use heat and humidifier moisture exchanger (HME). Maintenance of anesthesia will be done using isoflurane 1.2% in oxygen: air 50:50%.  Maintenance doses of Vecuronium 0.25 mg/kg. Inj. Paracetamol 15 mg/kg IV is given.

Hemodynamic parameters like MAP, SBP, DBP, SPO2 and HR will be observed immediate post-intubation, 2minutes, 5 minutes, 10minutes post-intubation and 5 minutes interval till 30 minute and 15 minutes interval till extubation.

On completion of surgery, anesthetic agents will be discontinued allowing recovery of consciousness. The muscle relaxation will be reversed with a combination of neostigmine 0.05 mg/ kg and glycopyrrolate 0.01 mg/kg. The patient will be smoothly extubated without bucking on the endotracheal tube after extubation criteria are met, and the patients will be shifted to post anaesthesia care unit.

 

The intensity of sore throat will be recorded at 0 h (on arrival to post-anesthesia care unit(PACU)), 4h, 8h, 12h, 24h and 48h postoperatively.

 

These symptoms will be scored by the investigator who will be blinded to the study drug.

 
 
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