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 type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 160 (estimated) |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | March 4, 2019 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT03812718 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
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Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Principal investigator: Nitin Sethi, DNB — Sir Ganga Ram Hospital
- Study coordinator: Nitin Sethi, DNB
- Email: nitinsethi77@yahoo.co.in
- Phone: 00919717494498
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.