Clinical trial NCT03812718: Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholelithiases
Cholecystolithiasis
Lead sponsor: Sir Ganga Ram Hospital
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 160-patients will be randomly divided into one of the two groups:

Group-I (ETT group, n= 80) ETT will be used as the airway device for maintaining ventilation

Group-2 (PLMA group, n= 80) PLMA will be used as the airway device for maintaining ventilation
Primary purpose: OTHER

Brief 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

Detailed description: Endotracheal tube (ETT) is the gold standard conduit for providing controlled ventilation during general anesthesia (GA). However, since the introduction of classic laryngeal mask airway (LMA) in the 1980's and serial evolution of supra-glottic airway devices (SGA) thereafter, LMAs have become a reliable alternative to ETT for carrying out controlled ventilation. Interestingly, of the additional advantages that the LMA proffers, including, a lower incidence of postoperative sore throat (POST) and superior hemodyamic profile during surgery; its ability to maintain equivalent depth of anesthesia (in comparison to when ETT-GA) with lower anesthetic requirement, is intriguing.

A handful of studies have demonstrated that the end-tidal isoflurane concentration required for maintenance of GA is 0.2 -0.53% greater with use of ETT as compared to LMA. However, the evidence generated by these studies remains unsubstantiated because in them, anaesthetic gas concentration was titrated to patient's clinical profile like heart rate and blood pressure without the backing of specific protocol for maintaining depth-of-anaesthesia. Therefore, for credible evidence, assessment of quantitative anesthetic requirement for achieving and sustaining a steady anesthesia depth with either LMA or ETT warrants confirmation with the use of an objective depth-of-anesthesia monitor, such as, bispectral index (BIS).

Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (502/DEL/2003) computer-controlled and BIS-guided automated anesthesia delivery system. CLADS, which runs on a control algorithm based on the relationship between diverse rates of propofol infusion and the processed EEG variable; delivers propofol infusion at a rate which is continuously adjusted by patient's state of depth of anesthesia as per BIS monitoring input. This automated system maintains anaesthesia depth with high accuracy and objectively determines propofol delivery quantitatively.

Of the several variants of SGA available today, the ProSeal laryngeal mask airway (PLMA) 9 is preferred for controlled ventilation for its unique design that serves dual function of a ventilation tube and an oropharyngeal drainage tube for excluding gastric contents from getting aspirated through the peri-laryngeal cuff seal.

Given that CLADS can help us to accurately quantify anaesthesia, we hypothesize that there is no difference in anesthesia requirement for GA maintained through an ETT or a PLMA. This randomized controlled study aims to compare: anaesthesia requirement as determined by total propofol consumption (primary objective); intraoperative hemodynamic profile and incidence of POST (secondary objectives) in patients undergoing laparoscopic surgery with controlled ventilation via ETT or PLMA.

Eligibility criteria: 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 outcomes:
measure: Change in Propofol usage in milligrams
timeFrame: From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
Secondary outcomes:
measure: Anaesthesia depth consistency using BIS scores
timeFrame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
measure: Evaluation of propofol anaesthesia delivery system
timeFrame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
measure: Change in Intra-operative heart Rate (beats per minute)
timeFrame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
measure: Change in Intra-operative systolic , diastolic, and mean (mmHg)
timeFrame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
measure: Early Recovery from anesthesia
timeFrame: From end of anaesthesia till 20-minutes postoperatively
measure: Post operative sedation
timeFrame: From the end of anaesthesia till 24-hours, postoperatively
measure: Incidence of postoperative sore throat
timeFrame: From the end of anaesthesia till 24-hours, postoperatively
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
state: Delhi
Study officials:
affiliation: Sir Ganga Ram Hospital
name: Nitin Sethi, DNB
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Ganga Ram Hospital
name: Amitabh Dutta, MD
role: STUDY_DIRECTOR
affiliation: Sir Ganga Ram Hospital
name: Jayashree Sood, MD, FFRCA
role: STUDY_CHAIR
References: