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

NCT03812718 | Recruiting DMC

• 1 other identifier: EC/01/19/1464
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Conditions

Cholelithiases; Cholecystolithiasis

Outcome Measures

Primary Outcomes (1)

• Change in Propofol usage in milligrams

  Comparison of quantitative difference in propofol requirement between the two groups

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

Secondary Outcomes (7)

• Anaesthesia depth consistency using BIS scores

  From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively

• Evaluation of propofol anaesthesia delivery system

  From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively

• Change in Intra-operative heart Rate (beats per minute)

  From beginning of anaesthesia (0-hours, baseline) till 3 hours intraoperatively

• Change in Intra-operative systolic , diastolic, and mean (mmHg)

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

• Early Recovery from anesthesia

  From end of anaesthesia till 20-minutes postoperatively

Study Arms (2)

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).

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.

Device: ProSeal Laryngeal Mask Airway (PLMA)

Interventions

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.

ETT Group

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.

PLMA Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Sir Ganga Ram Hospital

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

MeSH Terms

Conditions

Cholelithiasis; Cholecystolithiasis

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases

Study Officials

• Nitin Sethi, DNB

  Sir Ganga Ram Hospital

  PRINCIPAL INVESTIGATOR

• Amitabh Dutta, MD

  Sir Ganga Ram Hospital

  STUDY DIRECTOR

• Jayashree Sood, MD, FFRCA

  Sir Ganga Ram Hospital

  STUDY CHAIR

Central Study Contacts

Nitin Sethi, DNB

CONTACT

00919717494498; nitinsethi77@yahoo.co.in

Amitabh Dutta, MD

CONTACT

+911142252523; duttaamiatbh@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The attending anaesthesiologist will not be blinded to the technique utilized to administer GA. An independent assessor unaware of the technique utilized for administering GA will analyse the intraoperative data and conduct the postoperative follow up
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant & Associate Professor

Model Details: 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

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: January 23, 2019
• Study Start: March 4, 2019
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)