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Simpler and less invasive device to give general anesthesia to children undergoing laparoscopic surgery

A prospective observational study to assess the effectiveness and safety of second generation supraglottic airway devices in laparoscopic surgeries in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/05/008470
Enrollment
50
Registered
2017-05-03
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: null- Children scheduled for routine elective laparoscopic surgeries

Interventions

Intervention1: Supraglottic devices (i-gel, proseal LMA): Use of supraglottic devices (i-gel, proseal LMA) that are routinely used for ventilation during general anesthesia both in adults and children

Sponsors

Army Hospital Research Referral New Delhi India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients scheduled for elective laparoscopic surgery in a tertiary care pediatric surgery center and their parents consenting for their children to participate in the study protocol will be included in the study. ASA I-II BMI 20-30 kg/m2

Exclusion criteria

Exclusion criteria: Respiratory tract infection Inadequate fasting as per standard fasting guidelines Difficult airway Emergency surgery

Design outcomes

Primary

MeasureTime frame
Oro-pharyngeal seal pressure (OSP) of the supraglottic deviceTimepoint: 2 min after insertion, 10 min after creation of pneumoperitoneum, every 30 min thereafter till the end of surgery

Secondary

MeasureTime frame
heart rate, non-invasive blood pressure, SpO2, ECG, Peak airway pressure, respiratory rate, tidal volume will be continuously monitored and notedTimepoint: every 30 min from the start of anesthesia;sore throat, hoarseness of voice, oral bleedingTimepoint: At extubation 2 h after extubation 6 h after extubation

Countries

India

Contacts

Public ContactRakhee Goyal

Army Hospital R and R

rakheegoyalkumar@gmail.com7798225637

Outcome results

None listed

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