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CTRI Number  CTRI/2017/06/008944 [Registered on: 29/06/2017] Trial Registered Prospectively
Last Modified On: 24/06/2017
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Routine Data Based Study 
Study Design  Single Arm Study 
Public Title of Study   The effect of nebulised magnesium sulphate on the incidence of sore throat after removal of endotracheal tube following general anaesthesia  
Scientific Title of Study   The effect of nebulised magnesium sulphate on the incidence of post operative sore throat 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mallika Balakrishnan 
Designation  Additional Professsor, Department of Anaesthesiology, Regional Cancer Centre 
Affiliation  Regional Cancer Centre 
Address  ULRA 59 Ulloor Lane Jagathy PO Trivandrum,Kerala,India
Divison of Anaesthesiology, Regional Cancer Centre, Chalakkuzhi, trivandrum Kerala-695011
Thiruvananthapuram
KERALA
695014
India 
Phone  919847921958  
Fax    
Email  mallikarcc@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mallika Balakrishnan 
Designation  Additional Professsor, Department of Anaesthesiology, Regional Cancer Centre 
Affiliation  Regional Cancer Centre 
Address  ULRA 59 Ulloor Lane Jagathy PO Trivandrum,Kerala,India
Divison of Anaesthesiology, Regional Cancer Centre, Chalakkuzhi, trivandrum Kerala-695011
Thiruvananthapuram
KERALA
695014
India 
Phone  919847921958  
Fax    
Email  mallikarcc@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Mallika Balakrishnan 
Designation  Additional Professsor, Department of Anaesthesiology, Regional Cancer Centre 
Affiliation  Regional Cancer Centre 
Address  ULRA 59 Ulloor Lane Jagathy PO Trivandrum,Kerala,India
Divison of Anaesthesiology, Regional Cancer Centre, Chalakkuzhi, trivandrum Kerala-695011
Thiruvananthapuram
KERALA
695014
India 
Phone  919847921958  
Fax    
Email  mallikarcc@yahoo.co.in  
 
Source of Monetary or Material Support  
Regional cancer centre Medical College Campus, Chalakkuzhi, Thiruvananthapuram, Kerala 695011 
 
Primary Sponsor  
Name  Dr Mallika Balakrishnan 
Address  ULRA 59 Ulloor Lane Jagathy PO Trivandrum, Kerala,India-695014 
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 Mallika Balakrishnan  Regional Cancer Centre  Department of Anaesthesiology,Regional Cancer Centre, Medical College Campus, Chalakkuzhi, Thiruvananthapuram, Kerala 695011
Thiruvananthapuram
KERALA 
9847921958

mallikarcc@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee,Regional Cancer Centre,Thiruvananthapuram  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  presence of post operative sore throat following extubation after general anaesthesia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either gender , aged 18-60, belonging to American Society of Anaesthesiologists (ASA) status 1 or 2 undergoing elective surgery of two hours or more duration requiring endotracheal intubation after acquiring consent stating the procedure  
 
ExclusionCriteria 
Details  Patients with neuromuscular disease
Allergy or hypersensitivity to drugs,
Undergoing neck surgeries
Unwilling patients
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Presence of post operative sore throat at rest   immediately after extubation of the endotracheal tube
2 hours after extubaion of the endotracheal tube
4 hours after extubaion of the endotracheal tube
10 hours after extubaion of the endotracheal tube
24 hours after extubaion of the endotracheal tube 
 
Secondary Outcome  
Outcome  TimePoints 
Presence of sore throat on swallowing   immediately after extubation of the endotracheal tube
2 hours after extubaion of the endotracheal tube
4 hours after extubaion of the endotracheal tube
10 hours after extubaion of the endotracheal tube
24 hours after extubaion of the endotracheal tube 
 
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   N/A 
Date of First Enrollment (India)   01/08/2017 
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   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

THE EFFECT OF NEBULISED MAGNESIUM SULPHATE ON THE INCIDENCE OF POST OPERATIVE SORE THROAT


PRINCIPAL INVESTIGATOR


Dr.Mallika Balakrishnan , Additional Professor, Department of Anaesthesiology

 

CO-INVESTIGATORS

 

Dr.Bhagyalakshmi Ramesh,Assistant Professor,Department of Anaesthesiology

 

 Dr.KumarB.G,Junior Resident , Department of Anaesthesiology


BACKGROUND OF THE STUDY


Intravenous magnesium sulphate is extensively and routinely used in anaesthetic as well as critical care for a wide range of conditions such as Tocolysis, Toxemia of pregnancy , Asthma, and Torsades de pointes{1} .The general incidence of sore throat after tracheal intubation for general anaesthesia varies from 6.6 to 90%{2}It also increases the duration of hospital stay{3} . It is known that NMDA (N-Methyl D-Aspartate)receptors play a role in nociception and inflammation {4,5}. Magnesium sulphate works as an antagonist of the NMDA receptor.{6}This particular study aims to use magnesium sulphate in the nebulized format at very low doses from that normally used in other conditions to study the effect it has in reducing the sensation of post operative sore throat

 

AIM OF THE STUDY


To evaluate the efficacy of pre operative magnesium sulphate nebulization in reducing the incidence of post operative sore throat following general anaesthesia


DESIGN OF THE STUDY


Routine data based study

 

STUDY PERIOD


2017-2018


STUDY POPULATION :


45 patients will be included in the study, and they will be nebulized with 3ml of 225mg isotonic magnesium sulphate for 15 mins pre op,5 minutes prior to induction.The results will be compared with an equal number of controls who are routinely nebulized with 3ml  saline for 15 mins , 5 mins prior to induction

 

SETTING OF THE STUDY


 DEPARTMENT OF ANAESTHESIOLOGY, REGIONAL CANCER CENTER, TRIVANDRUM

 

INCLUSION CRITERIA


Patients of either gender , aged 18-60, belonging to American Society of Anaesthesiologists (ASA) status 1 or 2 undergoing elective surgery of two hours or more duration requiring endotracheal intubation after acquiring consent stating the procedure

 

 EXCLUSION CRITERIA


Patients with neuromuscular disease

Allergy or hypersensitivity to drugs,

Undergoing neck surgeries

Unwilling patients

 

METHOD OF STUDY

 

 The subjects under study will undergo overnight fasting and premedication with oral alprazolam 0.5 mg and pantoprazole 40mg HS and DOS morning.

 

The study population will be nebulized with 3ml of 225mg isotonic magnesium sulphate for 15 minutes, 5 minutes prior to induction.

 

Nebulisation by the OT staff, briefed by the anaesthesiologists

 

Standard monitoring ,intravenous access will secured.

 

Anaesthesia will be induced with fentanyl 2 mcg/kg and propofol 2mg/kg. Tracheal intubation will be facilitated by vecuronium 0.1mg/kg

 

7mm ETT tube (PVC) in female patients and 8 mm ETT tube (PVC) in male patients will be the standard sizes chosen

 

 The ETT cuff will be inflated with air.

 

The cuff pressure will be checked just after intubation using handheld tracheal cuff pressure monitor and then every 30 minutes till the end of surgery and will be maintained at 20 cm of H2O.

 No nasogastric tube will be inserted.

Maintenance of Anesthesia will be with  IPPV with air : oxygen mixture with fio2 of 45% and  1.8% of sevoflurane and intermittent doses of vecuronium as required.

Reversal of neuromuscular blockade with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg.

Extubation will be after the standard extubation criteria were met, and the patients will be shifted to PACU.

 

 

CONTROL GROUP


The control group is taken as the group of patients who were nebulized with 3ml of NS for 15 mins pre op, 5 minutes prior to induction and data for post operative throat which was tabulated for all the patients nebulized with NS in the year 2016 shall be acquired for comparison process

 

 

DATA COLLECTION AND ANALYSIS

 

Presence of sore throat will be noted at rest and on swallowing immediately after extubation, and 2 h, 4 h, 10h and 24 h postoperatively

 

Drug-related side effects will be noted , if any. Data will be expressed as mean, and 95% confidence interval of mean.

 

For categorical data, frequency and percentage of distribution will be calculated and for comparison between groups,Chi square /fisher’s exact test will be used

         Fisher’s exact test; P < 0.05 will  be considered statistically significant.

For quantitative (continuous data) , mean , standard deviation and range  will be calculated .

 For comparison of quantitative data between groups , students t test  will be used


REFERENCE

PARENT STUDY.Yadav M, Chalumuru N, Gopinath R. Effect of magnesium sulfate nebulization on the incidence of postoperative sore throat. J AnaesthesiolClinPharmacol 2016;32:168-71

1.http://reference.medscape.com/drug/mgso4-magnesium-sulfate-344444

2.Sumathi PA, Shenoy T, Ambareesha M, Krishna HM. Controlled comparison between betamethasone gel and lidocaine jelly applied over tracheal tube to reduce postoperative sore throat, cough, and hoarseness of voice. Br J Anaesth 2008;100:215-8.

3.. Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth 2002;88:582-4.

4.Lin CY, Tsai PS, Hung YC, Huang CJ. L-type calcium channels are involved in mediating the anti-inflammatory effects of magnesium sulphate. Br J Anaesth 2010;104:44-51.

5. Zhu MM, Zhou QH, Zhu MH, Rong HB, Xu YM, Qian YN, et al. Effects of nebulized ketamine on allergen-induced airway hyperresponsiveness and inflammation in actively sensitized BrownNorway rats. J Inflamm (Lond) 2007;4:10

6.Turpin F, Dallérac G, Mothet JP. Electrophysiological analysis of the modulation of NMDAreceptors function by D-serine and glycine in the central nervous system. Methods MolBiol 2012;794:299-312.


 
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