| CTRI Number |
CTRI/2026/01/101816 [Registered on: 22/01/2026] Trial Registered Prospectively |
| Last Modified On: |
06/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study of two different doses of a sedative medicine to reduce agitation after eye surgery in children |
|
Scientific Title of Study
|
Comparative Evaluation On Efficacy And Safety Of Two Different Doses Of Intravenous Dexmedetomidine On Postoperative Emergence Delirium In Paediatric Patients Undergoing Eye Surgery- A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aikta Gupta |
| Designation |
Specialist Grade I, Department Of Anaesthesiology |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi |
| Address |
Room 227, Second Floor, Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi
East
DELHI
110031
India |
| Phone |
9643308230 |
| Fax |
|
| Email |
aiktab@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati Singh |
| Designation |
Senior Resident, Department Of Anaesthesiology |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi |
| Address |
Second floor, Department of Anaesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi
East
DELHI
110031
India |
| Phone |
9406710501 |
| Fax |
|
| Email |
swati.singh04832@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati Singh |
| Designation |
Senior Resident, Department Of Anaesthesiology |
| Affiliation |
Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi |
| Address |
Second floor, Department of Anaesthesiology, Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi
DELHI
110031
India |
| Phone |
9406710501 |
| Fax |
|
| Email |
swati.singh04832@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi (110031), India |
|
|
Primary Sponsor
|
| Name |
Chacha Nehru Bal Chikitsalaya |
| Address |
Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi (110031), India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Manoj Gupta |
Chief Medical Officer (NFSG) |
| Shilpa Agarwal |
Assistant Professor, Department Of Anaesthesiology |
| Swati Singh |
B-304, Mayurdhwaj Apartment, Geeta Colony, Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swati Singh |
Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi |
Department of Anaesthesiology, Second floor,Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi (110031), India
East
DELHI |
9460710501
swati.singh04832@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H10-H11||Disorders of conjunctiva, (2) ICD-10 Condition: H00-H05||Disorders of eyelid, lacrimal system and orbit, (3) ICD-10 Condition: H49-H52||Disorders of ocular muscles, binocular movement, accommodation and refraction, (4) ICD-10 Condition: H15-H22||Disorders of sclera, cornea, iris and ciliary body, (5) ICD-10 Condition: H26||Other cataract, (6) ICD-10 Condition: H55-H57||Other disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj. Dexmedetomidine |
Inj. Dexmedetomidine 0.2 mcg/ml diluted up to 10 ml with normal saline given over 10 minutes, 15 minutes prior to end of surgery. |
| Intervention |
Inj. Dexmedetomidine |
Inj. Dexmedetomidine 0.3 mcg/ml diluted up to 10 ml with normal saline given over 10 minutes, 15 minutes prior to end of surgery |
| Comparator Agent |
Normal Saline |
10 ml normal saline given over 10 minutes, 15 minutes prior to end of surgery |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I-II for elective unilateral eye surgery. |
|
| ExclusionCriteria |
| Details |
History of developmental delay, neurological or psychiatric disorder, heart diseases like cardiac arrhythmia, significant bradycardia, conduction block |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of postoperative emergence delirium by using Paediatric Anaesthesia Emergence Delirium Scale |
At immediate postoperative period (baseline), after that at 10 minutes, at 20 minutes, at 40 minutes and at 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Severity of postoperative emergence delirium using Paediatric Anaesthesia Emergence Delirium Scale |
At immediate postoperative period (baseline), after that at 10 minutes, at 20 minutes, at 40 minutes, at 60 minutes. |
| Extubation time measured in seconds |
At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes. |
| Pain score determined by Objective Pain Scale |
At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes |
| Sedation level measured by Ramsay Sedation Scale |
At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes. |
| Haemodynamic changes measured by Heart rate & Mean Arterial pressure |
At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes. |
| Adverse events measured in numbers |
At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
04/02/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
It is a prospective, randomised study comparing efficacy and safety of two different doses of intravenous dexmedetomidine versus placebo (normal saline) given prior to end of surgery to reduce incidence of Emergence delirium in paediatric patients undergoing eye surgery. Extubation time, severity of emergence delirium, postoperative pain, sedation level, adverse effects and haemodynamic parameters in immediate postopeartive period will also be monitored. Study will be conducted at Department of Anaesthesia at Chacha Nehru Bal Chikitsalaya. Study will include children between 2 to 10 years of age undergoing elective unilateral eye surgery belonging to ASA I and II. It will include 105 children within a course of one year after the initiation of study. |