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Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System

RecruitingNAAges 18 Years - 65 YearsAllSir Ganga Ram Hospital
NCT05967403 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Total intravenous anaesthesia (TIVA) is now a preferred technique for providing general anaesthesia (GA) because of its various inherent advantages like reduced postoperative nausea and vomiting (PONV), improved quality of post-operative recovery, anti-inflammatory and antioxidant action, anti-neoplastic activity, analgesic action, and absence of greenhouse effect. The evolution and advancement in automated anaesthesia delivery systems particularly for propofol have made propofol-TIVA more efficient by removing the human interface for both rate and concentration adjustments. Automated computer-controlled closed loop anaesthesia device adjusts propofol delivery based on patient's frontal cortex electrical activity determined by bispectral index (BIS). Closed loop anaesthesia delivery system (CLADS) is an indigenously developed patented (Patent no.502/DEL/2003 \& US 9,108,013 B2) computer

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📋 Eligibility rules (as published)
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.
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What it tests

  • Propofol
  • Propofol
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Where

1 site
Nitin Sethi
New Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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