Automated delivery of anesthesia using a closed-loop system
Official title: Anaesthesia Depth Consistency and System Performance of a Hermetic Closed-loop Anaesthesia Delivery System: A Randomized Controlled Study
Run by Sir Ganga Ram Hospital · NCT05967403 · Data updated 2026-11-12
This study is testing a new automated system that delivers anesthesia for surgery by adjusting the medication based on the patient's brain activity to see if it makes the process safer and more efficient.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | December 9, 2023 |
| Main results expected | October 2026 |
| Study ends | November 2026 |
| Registry record updated | April 27, 2026 |
| Trial ID | NCT05967403 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-65 years, classified as ASA physical status I-II, who are undergoing elective non-cardiac surgery lasting at least 60 minutes.
✕Probably not a fit
Patients with uncontrolled cardiovascular diseases, neurological disorders, or those requiring postoperative ventilation 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 evaluates a novel closed-loop anesthesia delivery system that automates the administration of propofol for total intravenous anesthesia (TIVA). By utilizing feedback from the patient's brain activity, measured through bispectral index (BIS), the system adjusts the dosage of propofol to maintain optimal anesthesia levels without human intervention. The goal is to enhance the efficiency and safety of anesthesia delivery during elective non-cardiac surgeries. Participants will be monitored to assess the system's performance compared to traditional methods.
Why it matters
Potential benefit: If successful, this system could lead to improved anesthesia management, reducing postoperative complications and enhancing recovery times for patients.
How similar studies have gone: Other studies have shown promise in automated anesthesia delivery systems, indicating potential for success with this innovative approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * aged 18-65 years- * ASA physical status I-II * undergoing elective non-cardiac surgery of minimum 60-minutes duration Exclusion Criteria: * Uncompensated cardiovascular disease (e.g., uncontrolled hypertension, atrio- ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction). * Hepato-renal insufficiency. * Any history of neurological disorder (e.g., epilepsy) or brain trauma * Uncontrolled endocrine diseases (e.g., diabetes mellitus, hypothyroidism). * Known allergy/hypersensitivity to the study drug. * History of any psychiatric disorder and/or drug dependence/substance abuse. * Requirement of postoperative ventilation. * Refusal to informed consent.
Where it's running
-
Nitin Sethi
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Principal investigator: Amitabh Dutta, MD, PGDHR — Sir Ganga Ram Hospital, New Delhi, INDIA
- Study coordinator: Amitabh Dutta, MD, PGDHR
- Email: duttaamitabh@yahoo.co.in
- Phone: +919810848064
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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.