Comparative evaluation of AMBU Auragain, i-gel and LMA Proseal in patients undergoing laparoscopic cholecystectomy under general anaesthesia

Rationale: AmbuAuraGain (AAG), i-gel and LMAProseal(PLMA) are someof the supraglottic devices which are used forcontrolled ventilation duringgeneral anaesthesia. However, there is limited literature comparing the threedevices for theirperformance in laparoscopic surgeries. Whatever studiesareavailable, their results are contradictory

Aim: To compare and evaluate the performance of three supraglotticdevices namelyAmbuAuraGain,i-gel and LMA Proseal in patients undergoinglaparoscopic cholecystectomy under general anaesthesia

Primary Objective

Tocompare the oropharyngeal leak pressure of AmbuAuraGain&i-gel withLMAProseal.

Secondary Objectives

Insertion characteristics –

Ease of insertion

Number of attempts for successfulinsertion

Success rate in first attempt

Maneuvers required for insertion

Ease of insertion of gastric tube

Hemodynamic changes

Complicationslike oropharyngeal trauma, sore throat

Setting: The study will be conducted in Department of Anaesthesiology,Critical Care and Pain Medicine, UCMS and GTB Hospital, Delhi

Study design: Randomized comparative study

Time frame: November 2019 to April 2021

Population/ participants: Patients of either gender, between 18-60years ASAgrade I/IIwith Modified Mallampatti class I/II admitted for electivelaparoscopic cholecystectomy under general anaesthesia

Exclusion Criteria:

BMI > 30 kg/m2

Pregnant women

Known or predicted difficult airway

Known case of COPD, asthma or anyother restrictive or obstructive respiratory pathology

Patients at high risk forpulmonary aspiration

Sample Size: 20 patients in each group, a total of 60 patients.

Method of Randomization: The patients will be assigned to one of the threegroups using computer generated random number table.

Group-A: AmbuAuraGain will be inserted as airway maintenance device

Group-I: i-gel will be inserted as airway maintenance device

Group-P: LMA Proseal will be inserted as airway maintenance device

**Methodology:**PAC will be done one day prior to surgery, a written informedconsent will be taken.In OT, all the routine monitors will be attached andbaseline vitals readings will be noted. An intravenous line will be secured.Depending on the randomization, one of the three devices (Ambu AuraGain, i-gelor PLMA) will be examined and prepared as per guidelines. Standard generalanaesthesia technique will be given. Supraglottic airway device will beinserted with the patient’s head in sniffing position. Correct placement ofdevice will be confirmed by bilateral chest expansion, auscultation of chestand appearance of first square wave on capnograph on monitor. An orogastrictube of appropriate size will be passed through the drainage tube followinglubrication and its position will be confirmed by epigastric auscultation ofair.

Outcome Measures:

**1.**Oropharyngeal leak pressure [Primary]

**2.**Ease of insertion

**3.**Number of attempts for successful insertion

**4.**Success rate in first attempt

**5.**Maneuvers required for insertion

**6.**Ease of insertion of gastric tube

**7.**Hemodynamic changes(HR, SBP, DBP)

**8.**Complications like oropharyngeal trauma, sore throat

STATISTICALANALYSIS

Statisticalanalysis will be done by using SPSSversion 20.0 or higher.All the 3 groups will be compared by one way ANOVA followed by Tukeys test at5% level of significance for quantitative parameters.Repeatedly measuredparameters will be compared by repeated measure ANOVA.Qualitative parameterswill be compared by Chi -square test/Fischer exact test. Bonferroni correction willbe done wherever required. A p value of <0.05 will be considered assignificant.