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.
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
- Are there results?
- Not yet: the study is under way
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)
Show all 9Show fewer
- 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
- 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
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.
- Conditions
- Cholelithiases, Cholecystolithiasis
- 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 group | Role | What they receive |
|---|---|---|
| ETT Group | Active comparator | Anesthesia 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 Group | Active comparator | Anesthesia 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.
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)
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
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
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
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
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
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
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.
- First posted23 Jan 2019
- Study start4 Mar 2019
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholelithiasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sir Ganga Ram Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nitin Sethi, DNB, Sir Ganga Ram Hospital
- Investigators
- Nitin Sethi, DNB, Principal investigator, Sir Ganga Ram HospitalAmitabh Dutta, MD, Study director, Sir Ganga Ram HospitalJayashree Sood, MD, FFRCA, Study chair, Sir Ganga Ram Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03812718
- Acronym / sponsor ID
- EC/01/19/1464
- Conditions
- Cholelithiases, Cholecystolithiasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Sir Ganga Ram HospitalUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| ETT Group | Active comparator | Device: Endotracheal tube (ETT)Anesthesia 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). |
| PLMA Group | Active comparator | Device: ProSeal Laryngeal Mask Airway (PLMA)Anesthesia 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA physical status I/II
- Undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | ETT Group |
| 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. | Device | PLMA Group |
Primary outcome
Change in Propofol usage in milligrams
Time frame: From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively
Comparison of quantitative difference in propofol requirement between the two groups
7 secondary outcomes
Anaesthesia depth consistency using BIS scores
Time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Evaluation of propofol anaesthesia delivery system
Time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Change in Intra-operative heart Rate (beats per minute)
Time frame: From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively
Change in Intra-operative systolic , diastolic, and mean (mmHg)
Time frame: From beginning of anaesthesia (0-hours, baseline) till 10 hours intraoperatively
Early Recovery from anesthesia
Time frame: From end of anaesthesia till 20-minutes postoperatively
Post operative sedation
Time frame: From the end of anaesthesia till 24-hours, postoperatively
Incidence of postoperative sore throat
Time frame: From the end of anaesthesia till 24-hours, postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitin Sethi, DNB principal investigator
Sir Ganga Ram Hospital
Amitabh Dutta, MD study director
Sir Ganga Ram Hospital
Jayashree Sood, MD, FFRCA study chair
Sir Ganga Ram Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitin Sethi, DNB (00919717494498, nitinsethi77@yahoo.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Propofol usage in milligrams (time frame: From beginning of anaesthesia (0-hours, baseline) till 4 hours intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.