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To know the effect of mouth gag an instrument placed during adenotonsillectomy surgery in children, on the eye nerve diameter which is indirect measure of raised intracranial pressure

Effect of mouth gag on Intracranial pressure (ICP) measured using optic nerve sheath diameter (ONSD) in paediatric patients undergoing adenotonsillectomy - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/12/099717
Enrollment
40
Registered
2025-12-23
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: J359- Chronic disease of tonsils and adenoids, unspecified

Interventions

Intervention1: Mouth gag insertion: To evaluate the effect of mouth gag placed intraoperatively during surgery on optic nerve sheath diameter using ultrasound Control Intervention1: In the absence of

Sponsors

Dr Reshma B M
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 5 to 15 years, Patients belonging to ASA- PS I- II, Patients posted for elective tonsillectomy/adeno-tonsillectomy under general anaesthesia.

Exclusion criteria

Exclusion criteria: Chronic ophthalmic diseases, History of previous ophthalmic surgery, Patients with increased ICP, or on medications, More than one attempt for endotracheal intubation, Patients with difficulty airway, Patients who refused to participate.

Design outcomes

Primary

MeasureTime frame
To assess the ONSD in patients undergoing adenotonsillectomy after placement of mouth gag.Timepoint: Baseline that is after induction of anaesthesia, after neck extension, after mouth gag placement, after 30 minutes of mouth gag placement, before removal of mouth gag, before extubation—

Secondary

MeasureTime frame
1.To assess the ONSD in patients undergoing adenotonsillectomy after neck extension. 2.To assess the heart rate, blood pressure changes on insertion of the mouth gag. 3.Side effects like postoperative nausea, vomiting & headache. Timepoint: 1.After neck extension, 2.After mouth gag insertion, during the surgery & after removal of mouth gag 3.Post operatively for 24hrs.—

Countries

India

Contacts

Public ContactReshma B M

Dr B R Ambedkar medical college and hospital

lucky3276@gmail.com8892019120

Outcome results

None listed

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