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Study Evaluating Controlled Propofol Anaesthesia in Children Undergoing Elective Airway Surgery

Propofol Target-Controlled Infusion using the Eleveld Model in Elective Paediatric Airway Surgery: A Prospective Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/02/103881
Enrollment
160
Registered
2026-02-16
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Health Condition 1: J989- Respiratory disorder, unspecified

Interventions

Intervention1: Nil: Nil

Sponsors

Indira Gandhi Instritute of Child Health
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists (ASA) physical status (PS) I, II 2. Age: 60 weeks post-conceptual age to 17 years 3. Patients who are scheduled for any elective (diagnostic or therapeutic) airway surgery

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Patients with mitochondrial disorder/ inborn error of lipid metabolism 3. Patients with known cardiac disease/dysfunction 4. Patients with a previous history of allergy to propofol 5. COLDS score less than 20 6. Patients who will be ventilated post-operatively for a surgical cause

Design outcomes

Primary

MeasureTime frame
To study the incidence of Peri-operative respiratory adverse events (any event of coughing, breath-holding, hypoxemia, laryngospasm, or bronchospasm, either alone or in combination) in airway surgeries done under the Eleveld propofol TCI model.Timepoint: From induction of anaesthesia to 30 minutes post-extubation

Secondary

MeasureTime frame
To determine the plasma concentration of propofol at the time of recoveryTimepoint: At extubation;To record the recovery timeTimepoint: At transfer out of the operating theatre;To note the total propofol consumption during surgeryTimepoint: From initiation to cessation of Propofol infusion.;To assess surgeon satisfaction using a 5-point Likert scaleTimepoint: At the end of surgery

Countries

India

Contacts

Public ContactDr Ridhi Rao

Indira Gandhi Institute of Child Health

ridhirao@gmail.com9900086577

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026