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Clinical Trials in India / NCT03812718
Recruiting

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

NCT03812718 · tracked via the Priya Life Science India tracker
Sponsor
Sir Ganga Ram Hospital
Phase
N/A
Started
2019-03-04
Last updated
2026-04-27

Condition(s) studied

CholelithiasesCholecystolithiasis

Investigational drug(s) / intervention(s)

Endotracheal tube (ETT)ProSeal Laryngeal Mask Airway (PLMA)

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.

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: 1. ASA physical status I/II 2. Undergoing elective laparoscopic cholecystectomy Exclusion Criteria: 1. Anticipated difficult airway 2. Body mass index \> 30-kg/m2 3. Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction) 4. Hepato-renal insufficiency 5. Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism) 6. Known allergy/hypersensitivity to the study drug (propofol) 7. Drug dependence/substance abuse/psychiatric illness 8. Requirement of postoperative ventilation 9. Refusal to informed consent

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Sir Ganga Ram Hospital New Delhi National Capital Territory of Delhi Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03812718 on ClinicalTrials.gov ↗ ← All trials in India