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Comparison of two topical drops in prevention of intraoperative eye movement affecting heart and postoperative pain

A comparison of topical 0.5% proparacaine and 0.75% ropivacaine in prevention of intraoperative oculo-cardiac reflex and post-operative pain in paediatric squint surgery: A randomised control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/06/025689
Enrollment
75
Registered
2020-06-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-03-06

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

Conditions

Health Condition 1: H500- Esotropia Health Condition 2: H501- Exotropia Health Condition 3: H502- Vertical strabismus

Interventions

Intervention1: Ropivacaine: Comparison of two drug Ropivacine and paracaine to see effect on oculocardiac reflex and post-operative pain against control (without any drug). One Drop will be administe

Sponsors

Director PGIMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. age group- 1-12 years 2. gender- male or female 3. ASA status- I or II 4. Patients scheduled for elective squint surgery under general anaesthesia unilateral or bilateral squint

Exclusion criteria

Exclusion criteria: 1. Children with previous or anticipated airway problems 2. Known drug sensitivity 3. Body weight less than 20% of the ideal body weight for that age. 4. Inability of parents to give consent for the study protocol 5. History of

Design outcomes

Primary

MeasureTime frame
To compare effect of topical 0.5% proparacaine and 0.75% ropivacaine versus control groups in prevention of incidence of intraoperative oculo-cardiac reflex in paediatric squint surgery under general anaesthesia To assess post-operative pain (FLACC score) in all the three groupsTimepoint: 6months

Secondary

MeasureTime frame
â?¢ Requirement for intra-operative and post-operative rescue analgesic drugs fentanyl and ibuprofen â?¢ To compare post-operative nausea vomiting â?¢ Change in pupil size following administration of local anaesthetic â?¢ Alignment of eyes by Hirschberg Test pre-operative 10 mins after induction before start of surgery and post-operatively after completion of surgery. â?¢ Any adverse effect on corneal endothelium by anaesthetic drops Timepoint: 6 months

Countries

India

Contacts

Public ContactDr Shweta Chaurasia

Advanced Eye Centre, PGIMER

shweta84omns@yahoo.com9990909575

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026