Comparison of 3 group of airway devices in relation to complications like sore throat.

Comparison of Ambu AuraGain at low cuff pressure, Ambu AuraGain at high cuff pressure and i-Gel in relation to incidence of postoperative upper airway complications.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2018/06/014651

Enrollment

140

Registered

2018-06-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: null- ASA 1 and 2

Interventions

Intervention1: Ambu AuraGain at low cuff pressure: Cuff is deflated to 25 cm H2O Intervention2: Ambu AuraGain at high cuff pressure: Cuff pressure at 60cm H2O Intervention3: i-gel: uncuffed Interventi

Eligibility

Inclusion criteria

Inclusion criteria: ASA physical status class 1,2.

Exclusion criteria

Exclusion criteria: 1. Neurological or psychiatric disorders. 2. Hoarseness of voice. 3. History of respiratory infection within a month. 4. Allergy to soyabean oil or egg and any of the study drugs. 5. Any contraindications for using SAD. 6. Patient needing their airway secured before administring muscle relaxant.

Design outcomes

Primary

Measure	Time frame
Incidence of sore throat in first 48 hours postoperativelyTimepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1 (8.00 AM) 4. Postopertive day 2 (8.00 AM)	—

Secondary

Measure	Time frame
incidence of dysphoniaTimepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1( 8.00 AM) 4. Postopertive day 2 (8.00 AM);any other complicationsTimepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1 (8.00 AM) 4. Postopertive day 2 (8.00 AM);Incidence of dysphagia Timepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1(8.00 AM) 4. Postopertive day 2(8.00 AM)	—

Measure

Time frame

incidence of dysphoniaTimepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1( 8.00 AM) 4. Postopertive day 2 (8.00 AM);any other complicationsTimepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1 (8.00 AM) 4. Postopertive day 2 (8.00 AM);Incidence of dysphagia Timepoint: 1. immediate post operative period 2. discharge from PACU (4.00 PM) 3. Postoprative day 1(8.00 AM) 4. Postopertive day 2(8.00 AM)

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Countries

India

Contacts

Public ContactRakesh kumar

maulana azad medical college

Rakeshrampal@gmail.com9968604214

Outcome results

None listed

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