MedTrace Logo

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

NCT03812718 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-04-27

No results posted yet for this study

Summary

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

Conditions

  • Cholelithiases
  • Cholecystolithiasis

Interventions

DEVICE

Endotracheal tube (ETT)

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.

DEVICE

ProSeal Laryngeal Mask Airway (PLMA)

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.

Sponsors & Collaborators

  • Sir Ganga Ram Hospital

    lead OTHER

Principal Investigators

  • Nitin Sethi, DNB · Sir Ganga Ram Hospital

  • Amitabh Dutta, MD · Sir Ganga Ram Hospital

  • Jayashree Sood, MD, FFRCA · Sir Ganga Ram Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • India

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03812718 on ClinicalTrials.gov