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CTRI Number  CTRI/2017/07/009129 [Registered on: 27/07/2017] Trial Registered Retrospectively
Last Modified On: 21/07/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study on intraocular pressures in children undergoing eye surgeries  
Scientific Title of Study   A Prospective, Randomized study comparing the Intraocular pressure changes and hemodynamic responses to insertion of Laryngeal mask Airway and Endotracheal Intubation in elective paediatric ophthalmic surgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrCKSwetha ramani 
Designation  Assisstant Professor 
Affiliation  Rajiv gandhi medical college and research institute 
Address  Department of Anaesthesiology SRM Medical College and Research Centre,Kattangulathur
Rajiv gandhi medical college and research institute chennai-3
Chennai
TAMIL NADU
603203
India 
Phone  9884782554  
Fax    
Email  swemohan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrAPushparani 
Designation  AssociateProfessor 
Affiliation  Srm Medical College and Research Centre 
Address  Department of Anaesthesiology Srm Medical College and Research Centre,Kattankulathur,603203
Department of Anaesthesiology Srm Medical College and Research Centre,Kattankulathur,603203
Chennai
TAMIL NADU
603203
India 
Phone  9003242601  
Fax    
Email  pushpa82_dr@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  DrCKSwetha ramani 
Designation  ASSISSTANT PROFESSOR 
Affiliation  Rajiv gandhi medical college and research institute 
Address  Department of Anaesthesiology Srm Medical College and Research Centre,Kattankulathur,603203
Department of Anaesthesiology Rajiv gandhi medical college and research institute chennai-3
Chennai
TAMIL NADU
603203
India 
Phone  9884782554  
Fax    
Email  swemohan@gmail.com  
 
Source of Monetary or Material Support  
Regional Ophthalmic Institute, Old No.132, Rukmani Lakshmipathy Salai, Egmore, Chennai, Tamil Nadu 600008 
 
Primary Sponsor  
Name  Rajiv gandhi medical college and research institute 
Address  Rajiv gandhi medical college and research institute, chennai-3 
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 
DrCKSwetha ramani  Regional institute opthalmology  Department of Anaesthesiology Old No.132, Rukmani Lakshmipathy Salai, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU 
9884782554

swemohan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Madras Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  peadiatric patients coming for elective ophthalmic surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group I   Patients subjected to LMA insertion  
Comparator Agent  Group II   Patients subjected to conventional Laryngoscopy and endotracheal intubation 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1 ASA I &II
2 Surgery
3 COPUR scale of airway assessment: 5 to 7 points
4 Should have given valid informed consent.
 
 
ExclusionCriteria 
Details  1 Not satisfying inclusion criteria.
2 Patients posted for emergency surgery
3 Patients with predicted difficult Intubation
4 Patients with increased Intraocular pressure
5 Children having upper respiratory infection, cardiovascular problem, respiratory disease, neck deformities, history of convulsions
• Allergy or contraindication for any of the drug used
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Intraocular Pressure changes with Laryngeal Mask Airway vs Endotracheal tube insertion  before and after insertion of Laryngeal Mask Airway And Endotracheal tube 
 
Secondary Outcome  
Outcome  TimePoints 
Systolic and Diastolic BP,Mean arterial pressure,Pulse rate, Respiratory rate,and Oxygen saturation   5min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   09/07/2014 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

SUMMARY

In the present study 60 patients belonging to ASAI& II of both sexes between age group 2 and 12 years were studied in two groups of 30 each as laryngeal mask airway group (LMA group/ group A) and Endotracheal tube intubation (ETT group/ group B). The data of both the groups were compiled and statistically analysed using Student ‘t’ test and p value was calculated. The IOP in LMA group was not raised during and after insertion of LMA. And remained progressively less at 30 seconds and 2 minute of study. In ETT group, the IOP had an initial fall after induction and later rose at 30 seconds  2nd  minute of intubating the trachea. (P<0.001). Statistically the rise in IOP was highly significant. The heart rate in LMA group showed a declining trend during an after induction, insertion and throughout the study. Whereas in ETT group after induction, there was an initial fall in heart rate from the baseline value. Then at 30 seconds and 2 minutes of insertion of tracheal tube the heart rate had progressive increase (p<0.001) In LMA group the systolic & diastolic blood pressure are decrease from its baseline value, after induction, during insertion and at 30 seconds and 2 minute of insertion. But blood pressure remained within physiological limits. 70 In ETT group ,the systolic & diastolic pressure had          an initial fall after induction and later on showed a rising trend at 30 seconds and 2 minutes of insertion of endotracheal tube.(p<0.001)

Hence this study is in favor of use of LMA to a conventional use of endotracheal        for administrating general anaesthesia specially for haemodynamically compromised patients and intraocular surgeries. Laryngoscopy and tracheal intubation is a time-tested method to achieve the airway control in anesthesia practice and resuscitation. However, it is associated with significant rise in IOP and cardiovascular response in the form of raised blood pressure and tachycardia because of sympathetic discharge following laryngotracheal stimulation . Many workers      have  made attempts     in       the     past   to      mitigate       or      prevent cardiovascular and ocular reactions especially the acute increase in intraocular pressure (IOP) associated with laryngoscopy and endotracheal intubation. Use of Brains’ laryngeal mask airway (LMA) as an alternative to endotracheal tube has attracted the attention of several workers with regard to haemodynamic and IOP changes.

CONCLUSION

1) Air way can be secured with confidence by LMA

2)      The art of placing LMA can be learnt very easily

3)      There is no difficulty in maintaining the anesthesia at desired level

4)      Patient tolerance to LMA is very good

5) The IOP does not raise when LMA is used hence can be safely used in patients with already raised IOP like  in Glaucoma and in penetrating eye injuries.

6) Endotracheal intubation is associated with rise in IOP, heart rate, and blood pressure.

7) Reusable LMA is  cost effective when compared with ETT since a single reusable LMA can be used uptill 20 times after ETO sterilization.

 

8) LMA can be used safely in patients who are haemodynamically compromised

The present study concludes that use of LMA as more beneficial when compared to ETT for general anesthesia in the group of patients studied


 
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