Performance Analysis of Hermetic Closed-loop Anesthesia Delivery System
ConditionAnesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSir Ganga Ram Hospital
About this trial
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-controlled anaesthesia delivery system which works with feedback loop information elicited by BIS monitoring and delivers propofol TIVA to the patient via a non-TCI automated infusion pump. It has been an extensively used and validated in patients undergoing both cardiac and non-cardiac surgical procedures.
A new compact and upgraded version of CLADS is now available. This new version incorporates the anesthetic depth monitor, hemodynamic monitor, controller, user interface and actuator syringe pump into a single, compact and user-friendly module.
The investigators aim to conduct a prospective randomized pilot study comparing the new CLADS and older CLADS version with respect to: adequacy of anaesthesia depth maintenance, performance characteristic of propofol delivery system, propofol requirement, haemodynamics stability, recovery from anesthesia and postoperative sedation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 18-65 years-
ASA physical status I-II
undergoing elective non-cardiac surgery of minimum 60-minutes duration
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Propofol
DrugPropofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the conventional closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.
Propofol
DrugPropofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the hermetic closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Conventional CLADS groupActive comparator 1 intervention
Group B: Hermetic CLADS groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anaesthesia depth consistency
It will be determined by the percentage of the anaesthesia time during which the BIS remained +/- 10 of the target BIS of 50
Time frame
From beginning of anaesthesia till 5- minutes post skin closureSecondary outcomes
1
Performance characteristic of propofol delivery system
It will be determined using the Varvel criteria parameter :median performance error (MDPE). This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. It's just an abstract number. Higher the value means worse performance of propofol delivery system. It is not a scale.
Time frame
From beginning of anaesthesia till 5- minutes post skin closure2
Performance characteristic of propofol delivery system
It will be determined using the Varvel criteria parameter: median absolute performance error (MDAPE).This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.Higher the value means worse performance of propofol delivery system. It is not a scale.
Time frame
From start of anesthesia till 5- minutes post skin closure3
Performance characteristic of propofol delivery system
It will be determined using the Varvel criteria parameter: wobble. This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.Higher the value means worse performance of propofol delivery system. It is not a scale.
Time frame
From start of anesthesia till 5- minutes post skin closure4
Performance characteristic of propofol delivery system
It will be determined using the Varvel criteria parameter: global score. It is calculated using the formula Median absolute performance error + wobble / percentage of the anesthesia time during which the BIS remained +/- 10 of the target BIS of 50. This parameter have no unit of measurement. Its just a abstract number.Higher the value means worse performance of propofol delivery system. It is not a scale.
Time frame
From start of anesthesia till 5- minutes post skin closureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov