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CTRI Number  CTRI/2023/08/057140 [Registered on: 31/08/2023] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Surgical and Anaesthesia 
Study Design  Single Arm Study 
Public Title of Study   Is there any relation of an increase in pressure inside the eyeball with behavioural changes after laparoscopic surgery in children?  
Scientific Title of Study   Does a change in optic nerve sheath diameter have an association with postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries? : An observational 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  Kausika S  
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room 718, Hostel 19,Department of Anaesthesiology, Pain Medicine and Critical Care,AIIMS, Ansari Nagar, South Delhi, 110029,India

New Delhi
DELHI
110029
India 
Phone  7502957597  
Fax    
Email  drkausika98@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Bharat Shah  
Designation  Assistant Professor  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room no-6,4th floor, Porta cabin, Department of Anaesthesiology, Pain Medicine and Critical Care, ward block,AIIMS, Ansari Nagar, South Delhi, 110029,India

New Delhi
DELHI
110029
India 
Phone  9892652781  
Fax    
Email  shreyabs@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Kausika S  
Designation  Junior Resident  
Affiliation  All India Institute of Medical Sciences, New Delhi  
Address  Room 718, Hostel 19,Department of Anaesthesiology, Pain Medicine and Critical Care,AIIMS, Ansari Nagar, South Delhi, 110029,India

New Delhi
DELHI
110029
India 
Phone  7502957597  
Fax    
Email  drkausika98@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, New Delhi, 110029 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences New Delhi  
Address  Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, Ansari Nagar, New Delhi, 110029 
Type of Sponsor  Research institution and hospital 
 
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 Kausika S  All India Institute of Medical Sciences, New Delhi   Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS, South Delhi
New Delhi
DELHI 
7502957597

drkausika98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee, AIIMS, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F05||Delirium due to known physiological condition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1.Patients aged 2-8 years
2. ASA physical status I/II
3. Patients undergoing laparoscopic surgeries under general anaesthesia
4. Cognitively intact children.  
 
ExclusionCriteria 
Details  1. Parent/ guardian refusal for inclusion in the study
2. Patients with age <2years and >8years
3. History of eye surgery
4. Current eyeball/orbit disease
5. Increased intracranial pressure
6. Seizure disorder, developmental disorder, psychiatric illness
7. History of adverse reaction to ultrasound gel or Tegaderm
8. ASA grade III/IV 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To determine the association between the intraoperative change in optic nerve sheath diameter(ONSD) & postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries   On table and at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes after spontaneous eye opening.  
 
Secondary Outcome  
Outcome  TimePoints 
1.To correlate ONSD with postoperative emergence delirium score in patients with postoperative emergence delirium
2.To correlate ONSD with postoperative nausea vomiting
3.To correlate postoperative emergence delirium with preoperative patient anxiety  
1. On table & at 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes after spontaneous eye opening.
2. Postoperatively at 30 minutes.
3. Preoperatively before 30 minutes.  
 
Target Sample Size   Total Sample Size="103"
Sample Size from India="103" 
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)   15/09/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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
Modification(s)  
In the laparoscopic surgeries, the carboperitoneum created causes an increase in the intracranial pressure. Optic nerve sheath diameter measurement is a simple bedside tool which can be used as a surrogate for an increased intracranial pressure. There are studies in adult population showing the correlation between
increased optic nerve sheath diameter intraoperatively and inadequate postoperative awakening; but no such studies exist in paediatric population. 

PRIMARY OBJECTIVE:
To determine the association between the intraoperative change in optic nerve sheath diameter (ONSD) and postoperative emergence delirium in paediatric patients undergoing laparoscopic surgeries

SECONDARY OBJECTIVES:
To correlate ONSD with postoperative emergence delirium score in patients with postoperative emergence delirium.To correlate ONSD with postoperative nausea vomiting and to correlate postoperative emergence delirium with preoperative patient anxiety

Sample size: 103 patients 

Inclusion criteria
1. Age 2 to 8 years
2. ASA physical status I/II
3. Patients undergoing various laparoscopic surgeries under general anaesthesia
4. Cognitively intact children

Exclusion criteria
1. Parental /guardian refusal for inclusion in the study
2. Patients with age < 2 years and >8 years
3. History of eye surgery
4. Current eyeball/orbit disease (e.g., cataract, glaucoma, retinal detachment)
5. Increased intracranial pressure (e.g., brain tumour, spinal cord lesion)
6. Seizure disorder, developmental disorder, psychiatric illness
7. History of adverse reaction to ultrasound gel or Tegaderm
8. ASA grade III/IV

On arrival of the patient to the operating room,  standard ASA monitoring will be employed.  General anaesthesia will be given to the patient. Ultrasonographic Measurement of Optic Nerve Sheath Diameter will be measured at three specific timepoints. T1, immediately after the induction of anaesthesia; T2, 30 minutes after intraperitoneal CO2 insufflation and T3, 10 min after releasing the pneumoperitoneum. In the PACU, the ED will be assessed on arrival to PACU and at each 5-minute interval till 30 minutes from the time of awakening and whenever the child becomes agitated. Postoperative nausea and vomiting will be assessed on a 4 point objective score till 3o minutes after the surgery.  The modified Yale preoperative anxiety scale will be used to assess preoperative anxiety in the preoperative holding area 30 minutes prior to surgery.

We hypothesize that in paediatric patients undergoing laparoscopic surgeries an intraoperative change of optic nerve sheath diameter will have an association with postoperative emergence delirium.
 
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