Anaesthesia for laser treatment of retinal disease in premature infants

Anaesthesia for laser treatment of retinopathy of the premature

Registry ID
ISRCTN22903257
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE4
Study type
OBSERVATIONAL
Sponsor
Radboud University Medical Center
Enrollment
150
Start date
2026-04-15
Completion date
2029-01-01
Last update
2026-08-17

Conditions

Summary

Retinopathy of prematurity (ROP)

Detailed description

The primary objective will be achieved by analyzing the primary and secondary anaesthesiological and opthalmological endpoints. The achievement of the secondary objective will be dependent on the final group size of the historical cohort. Primary endpoint: Respiratory deterioration, defined as an increase of ventilatory support in the first 24 hours postoperatively, compared to the preoperative ventilatory support requirement. Secondary endpoints: Perioperative, anesthesiological: 1. Number of airway management attempts 2. Saturation drop <85% SpO₂ 3. Thoracic rigidity 4. Laryngeal spasm 5. Aspiration 6. Bradycardia <100 bpm 7. Tachycardia (>160-180 depending on post-menstrual age [PMA]) 8. Hypotension (mean arterial blood pressure < PMA) with/without treatment 9. Hypertension (mean arterial pressure [MAP] >95th percentile based on PMA) 10. Preemptive medication 11. Rescue medication: yes/no Perioperative, ophthalmological: 1. Surgical working conditions perioperatively (visualization good/moderate/poor) 2. Total operating time and per eye in minutes 3. Number of coagulates 4. Postoperative complications (<8 weeks): yes/no 5. Progression of ROP to stage 4 or 5: yes/no Postoperative within 24 hours after the procedure: 1. Persistent respiratory/circulatory distress requiring conservative management: yes/no 2. Apnea: cessation of breathing >20 seconds or less with concomitant bradycardia (<60 bpm)/desaturation (<85% SpO₂), or an increase in episodes of apnea in the case of pre-existing apnea 3. Caffeine requirement postoperative: yes/no 4. Hypothermia <36.5 °C immediately after end of anesthesia/arrival from OR to the NICU: yes/no 5. Comfort score Number of study participants: A total of approximately 150 patients will be included, in order to obtain 100 patients that received anaesthesiological treatment as defined by current local protocol. The amount of patients in the historical cohort will add to these 100 patients. Sample size: For sample size calculatio

Interventions

Inclusion criteria

1. Have had laser treatment for ROP in Radboudumc/Amalia Children's Hospital 2. Age <1 year at time of surgery

Exclusion criteria

1. Registered statement by parents/caregivers of no agreement to participation in scientific research 2. Multiple surgeries that are not eye laser treatments during one session of anaesthesia

Locations

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