Examination of children with glaucoma using a new modality for sedation

Completed

• Conditions: Diseases of the eye and adnexa,

• Registration Number: CTRI/2019/01/017274
• Lead Sponsor: Medical Education Cell Postgraduate Institute of Medical Education and Research Chandigarh

Brief Summary

It is a randomized, prospective, interventional study and will be conducted at Advanced Eye Centre (AEC), Department of Ophthalmology, PGIMER, Chandigarh in collaboration with department of Anaesthesia. Patients will be divided in two groups: Group 3 ug/kg, Group 3.5µg /kg.

Children will be given intranasal dexmedetomidine (3/3.5µg/kg) using mucosal atomization device. The time of drug administration will be noted. Ramsay sedation score will be assessed after 10, 20 and 30 min thereafter.

When adequate sedative score is achieved, ophthalmic examination will be performed. If adequate sedation in not achieved then rescue sedation will be used and recorded.

Patient will be discharged after Revised Alderte Score of 9-10 is reached and the time of recovery will be noted. A note will be made of any complications like bradycardia, arrythmias, desaturation, reduction in respiratory rate will be made.  Parents satisfaction scoring will be done as good/ fair/poor.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-28
• Study Completion: 2019-10-04
• Last Update Posted: 2019-11-17

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 1. Children with age of 6 months to years requiring Examination under sedation following surgery for pediatric glaucoma.
• 2. ASA (American Society of Anaesthesiologists) physical status I/II.

Exclusion Criteria

Cardiorespiratory distress bradycardia upper respiratory tract infection liver disease seizures acute medical condition.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of children having successful examination without requiring rescue sedative agent at 30minutes after intranasal dexmedetomidine	30 minutes after intranasal dexmedetomidine

Secondary Outcome Measures

Name	Time	Method
1.Mean time of onset of adequate sedation score (Ramsay’s score)	2.Sedation scores at 10 minutes, 20 minutes and 30 minutes after administration

Trial Locations

Locations (1)

Postgraduate Institute of Medical Education and Research, Chandigarh; 🇮🇳 Chandigarh, CHANDIGARH, India

Postgraduate Institute of Medical Education and Research, Chandigarh

🇮🇳Chandigarh, CHANDIGARH, India

Dr Sushmita Kaushik

Principal investigator

9814813207

sushmita_kaushik@yahoo.com