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To compare the incidence of any respiratory events after total intravenous anaesthesia with Propofol and inhalational anaesthesia with Sevoflurane following removal of proseal laryngeal mask airway

Incidence of respiratory events in children following removal of Proseal laryngeal mask airway after total intravenous anaesthesia with Propofol and inhalational anaesthesia with Sevoflurane - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055369
Enrollment
86
Registered
2023-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Total intravenous Anaesthesia with Propofol: This group will be induced with intravenous fentanyl 2micrograms/kg followed by intravenous Propofol 3-5mg/kg and injection Vecuronium 0.1mg

Sponsors

Maulana Azad Medical College And Associated Lok Nayak Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.6months to 7years of age scheduled to undergo elective lower limb,lower abdominal and genitourinary surgeries 2.American Society of Anaesthesiologists Grade I and II 3.Patients in whom the anticipated duration of surgery <2 hours

Exclusion criteria

Exclusion criteria: 1.Recent [ 2.Congenital heart disease 3.Neurological disorder 4.Hiatal hernia 5.Known or predicted difficult airway

Design outcomes

Primary

MeasureTime frame
Incidence of any respiratory event [cough, biting on the airway device/teeth clenching,oxygen desaturation,breath holding,laryngospasm,bronchospasm or upper airway obstruction] during removal of Proseal laryngeal mask airway & emergence from anaesthesia.Timepoint: 2 hours

Secondary

MeasureTime frame
1.Prevalence of individual respiratory events. 2.Airway hyperreactivity score. 3.Emergence time. 4.Incidence of emergence agitation using a 4 point scale. 5.Duration of post anaesthetic care unit stay. 6.Post operative nausea & vomiting. 7.Hemodynamic parameters (systolic blood pressure,diastolic blood pressure,heart rate,oxygen saturation)during emergence. Timepoint: 24 hours

Countries

India

Contacts

Public ContactDr Anju Romina Bhalotra

Maulana Azad Medical College

drakgk@yahoo.co.in9968604219

Outcome results

None listed

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