Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Comparing anesthesia needs for ventilation with endotracheal tube versus 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

Run by Sir Ganga Ram Hospital · NCT03812718 · Data updated 2026-11-12

This study is testing if using a laryngeal mask airway instead of an endotracheal tube during surgery can provide the same level of anesthesia with less medication needed.

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment160 (estimated)
SponsorSir Ganga Ram Hospital
Academic / other
Locations1 site (New Delhi, National Capital Territory of Delhi)
StatusRecruiting
StartedMarch 4, 2019
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedApril 27, 2026
Trial IDNCT03812718 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients classified as ASA physical status I or II who are scheduled for elective laparoscopic cholecystectomy.

Probably not a fit

Patients with anticipated difficult airways, obesity (BMI > 30 kg/m2), or uncontrolled medical conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the anesthesia requirements for controlled ventilation using an endotracheal tube (ETT) versus a ProSeal Laryngeal Mask Airway (PLMA) during elective laparoscopic cholecystectomy. It aims to establish whether the PLMA can maintain equivalent anesthesia depth with lower anesthetic requirements compared to ETT. The study utilizes a closed loop anesthesia delivery system (CLADS) to measure and compare the anesthetic gas concentrations needed for both methods. The findings could provide valuable insights into optimizing anesthesia practices.

Why it matters

Potential benefit: If successful, this study could lead to reduced anesthetic requirements and improved recovery outcomes for patients undergoing laparoscopic cholecystectomy.

How similar studies have gone: Previous studies have suggested potential advantages of LMA over ETT, but this study aims to provide more robust evidence using objective monitoring techniques.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Sir Ganga Ram Hospital
    New Delhi, National Capital Territory of Delhi, India
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.