Automated delivery of anesthesia using a closed-loop system
Anaesthesia Depth Consistency and System Performance of a Hermetic Closed-loop Anaesthesia Delivery System: A Randomized Controlled Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (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 | NCT05967403 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled cardiovascular diseases, neurological disorders, or those requiring postoperative ventilation may not benefit from this study.
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 performed: Other studies have shown promise in automated anesthesia delivery systems, indicating potential for success with this innovative approach.
Eligibility criteria
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 this trial is running
New Delhi, National Capital Territory of Delhi
- 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
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.