Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway
Launched by SIR GANGA RAM HOSPITAL · Jan 19, 2019
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how much anesthesia is needed when using two different devices for breathing support during surgery: the endotracheal tube (ETT) and the ProSeal laryngeal mask airway (PLMA). Both devices help keep patients breathing safely while they are under general anesthesia, but the researchers want to find out if the PLMA requires less anesthesia than the ETT while still providing effective ventilation. They will measure the amount of a specific anesthetic drug called propofol that is used during the surgery to see if there is a difference between the two methods.
To participate in this study, individuals must be between the ages of 18 and 75 and scheduled for elective laparoscopic cholecystectomy, which is a surgery to remove the gallbladder. However, there are some important criteria that could exclude participation, such as having certain heart or breathing issues, being significantly overweight, or having an allergy to propofol. Participants will be randomly assigned to receive either the ETT or PLMA during their surgery, and the study aims to gather valuable information that could improve anesthesia practices in the future.
Gender
ALL
Eligibility 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
About Sir Ganga Ram Hospital
Sir Ganga Ram Hospital is a premier multi-specialty healthcare institution located in New Delhi, India, renowned for its commitment to delivering high-quality patient care and advancing medical research. Established in 1954, the hospital is equipped with state-of-the-art facilities and a team of highly skilled professionals dedicated to clinical excellence. As a clinical trial sponsor, Sir Ganga Ram Hospital actively engages in innovative research initiatives aimed at improving treatment outcomes and enhancing patient safety. Through its robust ethical framework and adherence to regulatory standards, the hospital fosters a collaborative environment for clinical research, contributing to the global medical community's efforts in developing effective therapies and interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New Delhi, Delhi, India
Patients applied
Trial Officials
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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