Comparison of awakening after two anaesthesia gases in babies undergoing eye surgery

Comparison Of Recovery Characteristics With Desflurane And Sevoflurane In Preterm And Ex-Preterm Infants Undergoing Retinopathy Of Prematurity Surgery: A Prospective Randomised Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/01/023001

Enrollment

Registered

2020-01-27

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: H351- Retinopathy of prematurity

Interventions

Intervention1: Desflurane Anaesthesa: Desflurane will be used to maintain anaesthesia at 0.9-1.1 MAC (infants- 9.4%). Control Intervention1: Sevoflurane anaesthesia: sevoflurane will be used to mainta

Eligibility

Inclusion criteria

Inclusion criteria: 1. Infants undergoing surgery for retinopathy of prematurity under general anaesthesia 2. Preterm and ex-preterm infants up to 60 weeks post gestational age.

Exclusion criteria

Exclusion criteria: 1. Infants with acute respiratory tract infection 2. Significant cardiovascular disease 3. Significant neurological disease 4. Already on ventilator support

Design outcomes

Primary

Measure	Time frame
Time for extubationTimepoint: Time for extubation	—

Secondary

Measure	Time frame
1. Recovery parameters a. Time to first limb movement b. Time to first cry c. Time to reach pre-induction BIS reading d. Corresponding BIS values at first limb movement, extubation, and at first cry e. Apnea, Breath holding, Laryngospasm or Desaturation after extubation 2. Number of infants requiring postoperative ventilator support 3. Neonatal pain agitation sedation scale (N-PASS) at 15, 30 minutes, 1 and 2 hours after extubation. 4. Time to accept feeds 5. Number of apnoea episodes Timepoint: 12 hours	—

Measure

Time frame

1. Recovery parameters a. Time to first limb movement b. Time to first cry c. Time to reach pre-induction BIS reading d. Corresponding BIS values at first limb movement, extubation, and at first cry e. Apnea, Breath holding, Laryngospasm or Desaturation after extubation 2. Number of infants requiring postoperative ventilator support 3. Neonatal pain agitation sedation scale (N-PASS) at 15, 30 minutes, 1 and 2 hours after extubation. 4. Time to accept feeds 5. Number of apnoea episodes Timepoint: 12 hours

—

Countries

India

Contacts

Public ContactDr Kanil Ranjith Kumar

All India Institute of Medical Sciences, New Delhi.

kanil.aiims@gmail.com8800314575

Outcome results

None listed

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