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Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway

ConditionsCholelithiasesCholecystolithiasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSir Ganga Ram Hospital

About this trial

Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anaesthesia (GA). however, the supra-glottic airway (SGA) devices in particular the laryngeal mask airway (LMA) and its variants have become a reliable alternative to ETT for carrying out controlled ventilation. Of the several variants of LMA available today, the proseal LMA (PLMA) is preferred for controlled ventilation. The various advantages of LMA includes, a lower incidence of postoperative sore throat and superior haemodynamic profile during surgery. However, one aspect of providing anaesthesia with LMA compared to ETT is the ability of LMA to maintain equivalent depth of anaesthesia with lower anaesthetic requirement, is quiet intriguing and evidence to this regard is very limited.

By measuring the anaesthesia requirement using a robust computerised delivery system such as the closed loop anaesthesia delivery system (CLADS) we can establish for sure the anaesthesia required for maintaining intraoperative mechanical ventilation with the use of these two (ETT and PLMA) airway management devices.

This randomised controlled study aims to calculate the anaesthesia requirement as determined by the total amount of propofol consumed for maintaining anaesthesia with ETT versus PLMA

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status I/II

Undergoing elective laparoscopic cholecystectomy

Disqualifiers

Anticipated difficult airway

Body mass index > 30-kg/m2

Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)

Hepato-renal insufficiency

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endotracheal tube (ETT)

    Device

    After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.

  • ProSeal Laryngeal Mask Airway (PLMA)

    Device

    After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: ETT GroupActive comparator 1 intervention
Group B: PLMA GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Propofol usage in milligrams

Comparison of quantitative difference in propofol requirement between the two groups

Time frame
From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively

Secondary outcomes

1

Anaesthesia depth consistency using BIS scores

Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e. BIS-50) in both the study arms.

Time frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
2

Evaluation of propofol anaesthesia delivery system

Determined by using Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score in both the study arms

Time frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
3

Change in Intra-operative heart Rate (beats per minute)

Comparison of intra-operative heart rate between both the arms will be done

Time frame
From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
4

Change in Intra-operative systolic , diastolic, and mean (mmHg)

Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done

Time frame
From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sir Ganga Ram Hospital

Lead sponsor

Source ClinicalTrials.gov
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