| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F05||Delirium due to known physiological condition, |
|
|
Intervention / Comparator Agent
|
|
|
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 |
|
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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. |