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A study comparing safety of two types of tubes used for anaesthesia in ear surgery

Randomized controlled trial on the safety of using laryngeal mask airway (LMA), compared to endotracheal tube (ETT) for myringoplasty and mastoid surgery taking less than one and half hours in adults

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2013/012
Enrollment
Unknown
Registered
2013-03-22
Start date
2013-04-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Anaesthesia in myringoplasty and mastoid surgery

Interventions

All patients will be premedicated with diazepam 5mg nocte and mane, metoclopramide 10 mg and omeprazole 40 mg on the preceding evening then 40 mg 2–6 hours before surgery. Anaesthesia will be induced

Sponsors

National Hospital of Sri Lanka
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age >18 years 2. ASA I or ASA II risk category

Exclusion criteria

Exclusion criteria: 1. ASA III or above 2. BMI >25kg/m2 3. Non consenting patients

Design outcomes

Primary

MeasureTime frame
1. Time taken to establish the airway 2. Duration of the surgery 3. Airway time 4. Removal time( last stitch to airway removal) 5. Awakening time( last stitch to responding to commands) 6. Haemodynamic and respiratory variables : heart rate, blood pressure, respiratory rate, SpO2, EtCO2 7. Complications of airway management devices : cough, laryngospasm, nausea, vomiting on emergence, subjective feeling of sore throat 8. Other serious complications : pulmonary aspiration, negative pressure pulmonary oedema [1. - 5. : During surgery and the recovery period 6. : prior to induction, after anaesthetic induction prior to airway insertion, 2 minutes after airway insertion, prior to LMA or ETT removal, 2 minutes after the removal, at discharge from the theatre 7. – 8. : from induction until discharge from the hospital ]

Secondary

MeasureTime frame
None [None]

Countries

Sri Lanka

Contacts

Public ContactDr. Ajantha Perera

Consultant Anaesthetist

ajantha_perera_2005@gmail.com

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026