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CholelithiasesNCT03812718

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

A study testing Endotracheal tube (ETT) and ProSeal Laryngeal Mask Airway (PLMA) in people with Cholelithiases and Cholecystolithiasis, run by Sir Ganga Ram Hospital at 1 site in India.

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Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Cholelithiases, Cholecystolithiasis
What is being tested?
Endotracheal tube (ETT) and ProSeal Laryngeal Mask Airway (PLMA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteIndia
Study dates
4 Mar 2019to Dec 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)
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  • Drug dependence/substance abuse/psychiatric illness
  • Requirement of postoperative ventilation
  • Refusal to informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

India1 site, 1 recruiting
  • Sir Ganga Ram Hospital

    New Delhi, National Capital Territory of Delhi, 110060

    Nitin Sethi, DNB, +911142252523, nitinsethi77@yahoo.co.in

    Amitabh Dutta, MD, +911142252523, duttaamiatbh@yahoo.co.in

    Recruiting

Other trials in India

About this study

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

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

Read the 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.

Being tested
Endotracheal tube (ETT), ProSeal Laryngeal Mask Airway (PLMA)
Medical subject headings
Cholelithiasis, Cholecystolithiasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT03812718
Study groupRoleWhat they receive
ETT GroupActive comparatorAnesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol 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. Intraoperative ventilation will be instituted through a polyvinyl chloride (PVC) ETT (Portex, Smiths Medical ASD, Inc, Minneapolis, USA). The size of the tube will be standardized for the male (7.5 mm ID) and the female (6.5 MM ID).
Receives: Device: Endotracheal tube (ETT)
PLMA GroupActive comparatorAnesthesia will be induced with fentanyl-citrate (3µg/kg) and propofol (dose determined by automated system based on continuous BIS feedback from the patients). Atracurium besylate 0.5-mg/kg will be given to facilitate placement of airway device. Propofol 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. intraoperative ventilation will be maintained with PLMA (Telefex Medical, Westmeath Ireland) whose size would be selected based on body weight. In patients weighing 30-50 kg PLMA # 3.0, 50-70 kg PLMA # 4.0, and 50-100 kg PLMA # 5.0 will be inserted.
Receives: Device: ProSeal Laryngeal Mask Airway (PLMA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Propofol usage in milligrams

    Comparison of quantitative difference in propofol requirement between the two groups

    Measured: From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively

Secondary outcomes (7)
  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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively

  5. Early Recovery from anesthesia

    Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted

    Measured: From end of anaesthesia till 20-minutes postoperatively

  6. Post operative sedation

    Will be assessed using Modified Observer's assessment of alertness/sedation scale (MOAA/S)

    Measured: From the end of anaesthesia till 24-hours, postoperatively

  7. Incidence of postoperative sore throat

    Comparison of post operative sore throat occurrence between the two groups

    Measured: From the end of anaesthesia till 24-hours, postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2019
  2. Study start4 Mar 2019
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03812718
Sponsor's protocol ID
EC/01/19/1464
Status last verified
Apr 2026
First submitted
19 Jan 2019
Last updated
27 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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