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CTRI Number  CTRI/2026/01/102501 [Registered on: 30/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Side-effects of anesthesia in children for eye surgeries 
Scientific Title of Study   Incidence of Morbidities Associated with General Anaesthesia in Paediatric Ophthalmic Surgeries: A Prospective Observational Study 
Trial Acronym  MAGIC-OS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anoopa Elizabeth Oommen  
Designation  Junior resident  
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9489839348  
Fax    
Email  anoopaelizabeth@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anoopa Elizabeth Oommen  
Designation  Junior resident  
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  9489839348  
Fax    
Email  anoopaelizabeth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anita Shirley Joselyn 
Designation  Professor  
Affiliation  Christian Medical College Vellore 
Address  Department of Anaesthesia, Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7358377164  
Fax    
Email  anshirl@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Fluid research Grant, Christian Medical College, Vellore, Tamil Nadu 632004.  
 
Primary Sponsor  
Name  Anoopa Elizabeth Oommen 
Address  Department of Anaesthesia, Christian Medical College, Vellore 632004 
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 
Anoopa Elizabeth Oommen   Christian Medical College   Department of Anaesthesiology, Christian Medical College, Vellore
Vellore
TAMIL NADU 		 9489839348

anoopaelizabeth@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Research Board (Ethics and Research Committee of Christian Medical College Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H598||Other intraoperative and postprocedural complications and disorders of eye and adnexa, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  ASA I-II, consent obtained from parent/guardian
 
 
ExclusionCriteria 
Details  ASA more than or equal to 3, syndromic/airway issues, refusal of consent 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the incidence of oculocardiac reflex in children undergoing ophthalmic surgeries under general anaesthesia.  From induction of anaesthesia till the end of surgery.  
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate intraoperative morbidities like change in hemodynamic parameters, IOP & occurrence of hypothermia
2. To assess immediate postoperative morbidities (laryngospasm, bronchospasm, nausea, vomiting, pain, emergence delirium).
3. To explore any association between patient/surgical/anesthetic factors & occurrence of morbidities.

 		 1. Intraoperatively - at baseline (before induction of anaesthesia), at 15 minutes of surgery, at 30 minutes of surgery, at 45 minutes of surgery, at 60 minutes of surgery & at the end of surgery.

2. Post operatively -
In PACU: at arrival to PACU, at 15 minutes after arrival to PACU, at 30 minutes after arrival to PACU & at discharge from PACU to ward.
In ward: At arrival to ward, at 6 hours after arrival to ward, at 12 hours after arrival to ward & at 24 hours after arrival to ward. 
 
Target Sample Size   Total Sample Size="115"
Sample Size from India="115" 
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)   10/02/2026 
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="0" 
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  

This prospective observational study will be conducted at Mary Taber Schell Eye Hospital, Christian Medical College, Vellore, over a period of two years. Children aged 0–12 years undergoing elective and emergency ophthalmic surgeries under general anaesthesia will be included. Standard anaesthetic practice as per institutional protocol will be followed. Intraoperative and postoperative morbidities will be monitored and documented up to 24 hours postoperatively using a structured proforma. The primary outcome will be the incidence of anaesthesia-related morbidities. Secondary outcomes include their association with demographic and surgical/anesthetic factors.

This study will help quantify the burden of anaesthesia-related morbidities in paediatric ophthalmic surgeries and contribute to strategies aimed at improving perioperative outcomes and patient safety.

 
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