Actively Recruiting
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
Led by Sir Ganga Ram Hospital · Updated on 2026-04-27
160
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the anesthesia requirements for controlled ventilation during laparoscopic cholecystectomy by comparing two airway devices: the endotracheal tube (ETT) and the ProSeal laryngeal mask airway (PLMA). The study aims to determine if there is a difference in the amount of propofol needed to maintain anesthesia using these devices. This is a randomized controlled trial using an automated delivery system to measure anesthesia depth and drug usage. Participants will receive anesthesia induced with fentanyl and propofol, with muscle relaxation assisted by atracurium. The anesthetic dosing will be adjusted automatically by a closed-loop anesthesia delivery system (CLADS) guided by bispectral index (BIS) monitoring targeting a BIS value of 50. Ventilation will be maintained either through a standard polyvinyl chloride ETT sized by gender or a PLMA sized by body weight. Both devices are used during the surgery to maintain controlled ventilation. During the study, participants will be monitored continuously for anesthesia depth using BIS, propofol consumption will be recorded from induction until 4 hours intraoperatively, and intraoperative heart rate and blood pressure will be tracked. Researchers will assess secondary outcomes including consistency of anesthesia depth, early recovery, postoperative sedation, and incidence of sore throat up to 24 hours after anesthesia. The total participation period covers the surgery and immediate postoperative recovery monitoring.
CONDITIONS
Brief Title
Comparison of Anaesthesia Requirement for Ventilation With Endotracheal Tube Versus Proseal Laryngeal Mask Airway
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
- Age between 18 and 65 years
You will not qualify if you...
- Anticipated difficult airway
- Body mass index over 30 kg/m2
- Uncompensated cardiovascular disease such as uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced left ventricular compliance, or diastolic dysfunction
- Hepato-renal insufficiency
- Uncontrolled endocrine diseases like diabetes mellitus or hypothyroidism
- Known allergy or hypersensitivity to propofol
- History of drug dependence, substance abuse, or psychiatric illness
- Need for postoperative ventilation
- Refusal to provide informed consent
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 hours during surgery
Participants undergo anesthesia induction followed by insertion of either an endotracheal tube (ETT) or ProSeal laryngeal mask airway (PLMA) for controlled ventilation during laparoscopic surgery. Anesthesia is maintained with propofol controlled by a closed-loop system guided by bispectral index (BIS) monitoring to maintain a consistent depth of anesthesia.
1 visit (in-person) on surgery day
Duration - Up to 24 hours post-anesthesia
Participants are monitored for early recovery from anesthesia, post-operative sedation, and incidence of postoperative sore throat up to 24 hours after anesthesia ends.
1 to 2 visits (in-person) during the first 24 hours after surgery
Trial Site Locations
Total: 1 location
1
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
Research Team
N
Nitin Sethi, DNB
A
Amitabh Dutta, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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