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Comparison of the effects of two breathing tubes used during surgery under anaesthesia such as supraglottic airway device and endotracheal tube on pressure surrounding the brain in patients undergoing surgeries

Comparison of the effects of supraglottic airway device and endotracheal tube on intracranial pressure in patients undergoing elective surgeries - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067189
Enrollment
90
Registered
2024-05-10
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: O- Medical and Surgical

Interventions

Intervention1: Supraglottic airway device: The supraglottic airway device (LMA Protector) will be inserted after induction and neuromuscular blockade to secure the airway. The optic nerve sheath diame

Sponsors

Government Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 65 years of either sex 2. American Society of Anaesthesiologist (ASA) physical status I-II patients electively scheduled for non-ophthalmic elective procedures under general anaesthesia

Exclusion criteria

Exclusion criteria: 1. American Society of Anaesthesiologist (ASA) physical status III or more 2. Morbid obesity (BMI more than 35 kilogram per square metre) 3. History or suspicion of difficult airway (airway difficulty score more than 8) 4. More than two attempts for SGA placement 5. Past history of intra cranial or ocular surgery, diabetic neuropathy, cerebral edema, glaucoma, any other condition with elevated ICP 6. Major maxillofacial trauma or cervical spine pathology 7. Potentially full stomach 8. Pregnant women 9. Surgery in prone position 10. Lack of consent to participate in the study

Design outcomes

Primary

MeasureTime frame
To compare the effect of supraglottic airway device (LMA Protector) and endotracheal tube on intra cranial pressure as measured through optic nerve sheath diameter (ONSD) using transocular ultrasonography in patients scheduled to undergo elective surgeries.Timepoint: Pre induction (T0), 1 min after SGA placement/ ETT intubation (T1), 5 minutes after SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT intubation (T10)

Secondary

MeasureTime frame
To compare the hemodynamic response as measured through SBP, DBP, MAP and HR at various time intervals during surgery for both supraglottic airway device (LMA Protector) and endotracheal tube.Timepoint: Pre induction (T0), 1 min after SGA placement/ ETT intubation (T1), 5 minutes after SGA placement/ ETT intubation (T5) and 10 minutes after SGA placement/ ETT intubation (T10);To compare the post-operative outcomes with respect to occurrence and severity of complications like sore throat, dysphagia and dysphonia for both supraglottic airway device (LMA Protector) and endotracheal tube.Timepoint: 1 hour, 6 hours and 24 hours after surgery;To compare the first attempt success rate between supraglottic airway device (LMA Protector) and endotracheal tube. Timepoint: After establishment of an effective airway;To compare the insertion time between supraglottic airway device (LMA Protector) and endotracheal tube. Timepoint: After establishment of an effective airway

Countries

India

Contacts

Public ContactDr Richa Saroa

Government Medical College and Hospital, Chandigarh

sanjeev_palta@yahoo.com9646121523

Outcome results

None listed

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