RecruitingNot ApplicableNCT03812718

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

Anaesthesia Requirements for Ventilation With Endotracheal Tube Versus ProSeal Laryngeal Mask Airway During Automated Feedback-Loop Controlled Total Intravenous Anaesthesia in Patients Undergoing Laparoscopic Cholecystectomy: A Randomised Controlled Study


Sponsor

Sir Ganga Ram Hospital

Enrollment

160 participants

Start Date

Mar 4, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria2

  • ASA physical status I/II
  • Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria9

  • 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
  • Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
  • Known allergy/hypersensitivity to the study drug (propofol)
  • Drug dependence/substance abuse/psychiatric illness
  • Requirement of postoperative ventilation
  • Refusal to informed consent

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Interventions

DEVICEEndotracheal 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.

DEVICEProSeal 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.


Locations(1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, India

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NCT03812718


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