FindTrial
Sign In

A study of two different doses of a sedative medicine to reduce agitation after eye surgery in children

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 - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/01/101816
Enrollment
105
Registered
2026-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H10-H11- Disorders of conjunctiva Health Condition 2: H00-H05- Disorders of eyelid, lacrimal system and orbit Health Condition 3: H49-H52- Disorders of ocular muscles, binocular movement, accommodation and refraction Health Condition 4: H15-H22- Disorders of sclera, cornea, iris and ciliary body Health Condition 5: H26- Other cataract Health Condition 6: H55-H57- Other disorders of eye and adnexa

Interventions

Intervention1: 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. Intervention2: Inj. Dexmedetomidi

Sponsors

Chacha Nehru Bal Chikitsalaya
Lead Sponsor
Manoj Gupta
Collaborator
Shilpa Agarwal
Collaborator
Swati Singh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: ASA grade I-II for elective unilateral eye surgery.

Exclusion criteria

Exclusion criteria: History of developmental delay, neurological or psychiatric disorder, heart diseases like cardiac arrhythmia, significant bradycardia, conduction block

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative emergence delirium by using Paediatric Anaesthesia Emergence Delirium ScaleTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, at 20 minutes, at 40 minutes and at 60 minutes—

Secondary

MeasureTime frame
Severity of postoperative emergence delirium using Paediatric Anaesthesia Emergence Delirium ScaleTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, at 20 minutes, at 40 minutes, at 60 minutes.;Extubation time measured in secondsTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes.;Pain score determined by Objective Pain ScaleTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes;Sedation level measured by Ramsay Sedation ScaleTimepoint: 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 pressureTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes.;Adverse events measured in numbersTimepoint: At immediate postoperative period (baseline), after that at 10 minutes, 20 minutes, at 40 minutes, at 60 minutes.—

Countries

India

Contacts

Public ContactSwati Singh

Chacha Nehru Bal Chikitsalaya, Geeta Colony, Delhi

swati.singh04832@gmail.com9406710501

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026