| 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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
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|
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
|
|
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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 |
|
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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 |