Comparing anesthesia needs for ventilation with endotracheal tube versus laryngeal mask airway
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
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT03812718 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients classified as ASA physical status I or II who are scheduled for elective laparoscopic cholecystectomy.
Not a fit: Patients with anticipated difficult airways, obesity (BMI > 30 kg/m2), or uncontrolled medical conditions may not benefit from this study.
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 performed: Previous studies have suggested potential advantages of LMA over ETT, but this study aims to provide more robust evidence using objective monitoring techniques.
Eligibility criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.