Comparative efficacy and safety of two supraglottic airway devices during general anaesthesia in children

Not yet recruiting

Conditions: ASA I and II children below 1 year of age posted for ophthalmic surgery of 20 min-2 hr duration

Registration Number: CTRI/2018/06/014473

Lead Sponsor: Department of Anaesthesiology Pain medicine and Critical care

Brief Summary: We will be comparing the efficacy and safety of i-gel supraglottic airway and self pressurizing air-q intubating laryngeal airway during general anaesthesia in infants. The study will include 100 infants, ASA I and II, posted for elective ophthalmic surgery of 20 min-2 hrs duration. All patients above 1 year of age, not willing to consent and infants with any airway anomalies, active URTI, known difficult airway or lung disease requiring high PEEP will be excluded from the study. Randomization will be done by computer generated random number tables and group allocation will be done by opening sealed opaque envelopes. The primary objective of our study is to compare the oropharyngeal leak pressure of i-gel and air-Qsp and the secondary objectives are to compare the two devices in terms of- number of attempts to successfully insert the device, time to insert, fibre-optic view of glottis through the device and post-operative complications like cough, laryngospasm and desaturation.

All ASA I-II infants will receive standardised general anaesthesia. A pre-anaesthetic check-up will be done for all patients one day prior to the surgery. On being shifted to operation theatre, the standard monitors will be attached. Anaesthesia will be induced by using sevoflurane in oxygen by increasing inspired concentration of sevoflurane (from 2-8%) till the loss of eyelash reflex. 22 or 24G IV cannula will be secured. Then intravenous fentanyl 1Î¼g/kg and atracurium 0.25 mg/kg will be given. After 3 minutes of intermittent positive pressure ventilation, appropriate size (depending on body weight) of supraglottic device (according to the group allocated) lubricated with jelly will be inserted and circuit attached. Chest rise and ventilation will be confirmed. Satisfactory SGA placement will be confirmed by the appearance of square wave capnogram and absence of leak around SGA. A maximum of 3 attempts will be allowed. If more than 3 attempts are required, then it will be considered as failure and an alternative device or endotracheal intubation will be done Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery. After initial measurement of oropharyngeal leak pressure, the breathing system will be briefly disconnected and a 3-mm fiberscope will be inserted through the airway port to evaluate glottic view. Anaesthesia will be maintained with isoflurane 1- 2% (MAC 0.8 â€“ 1.0) in O2: Air mixture with Fio2 of 0.5. Pressure controlled ventilation to be used to maintain normocarbia (35 â€“ 40 cm of H2O).. Intra-operative analgesia will be maintained by IV Paracetamol (7.5 mg/kg). At the end of surgery, isoflurane will be turned off & 100% O2 will be administered. Muscle relaxation will be reversed by intravenous neostigmine (50Î¼g/kg) & glycopyrrolate (10Î¼g/kg). Adequate tidal volume & regular respiration will be maintained. Oropharyngeal suctioning will be done & device will be removed. Presence of any blood stain or any tongue, lip or dental trauma will be noted. Any post-operative complication such as repeated episodes of cough, laryngospasm, bronchospasm or desaturation will be noted till 1 hr post operatively.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Infants below 1yr.
of age Posted for Only elective ophthalmic surgery ASA I & II patients Duration of surgery (20 mins-2 hrs).

Exclusion Criteria

All patients above 1 year of age Not willing to consent (Consent taken from parents) Infants with any-airway anomalies, active URTI, known difficult airway, lung disease requiring high PEEP.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oropharyngeal Leak Pressure (in cm H2O)	Oropharyngeal leak pressure will be measured at 3 times: after insertion and fixation of the device, 10 min after insertion and at the end of surgery

Secondary Outcome Measures

Name	Time	Method
1. First insertion success rate	2. Time to insert (in seconds)

Trial Locations

Locations (1): All India Institute Of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute Of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr Ravinder Kumar Pandey
Principal investigator
9868397817
ravindrapandey1972@gmail.com