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Assessing the Accuracy of Automated Anaesthesia Drug Delivery system during Surgery

Validation of Closed Loop Anaesthesia Delivery System (CLADS)-Predicted Plasma propofol concentrations againist Measured plasma propofol levels by RP-HPLC in adult patients undergoing Total intravenous anaesthesia - An Observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/05/110718
Enrollment
61
Registered
2026-05-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Nil: Nil Intervention2: Nil: Nil Intervention3: Nil: Nil

Sponsors

AIIMS Jodhpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age 18 to 65 years American Society of Anaesthesiologists Physical status 1 to 3 Undergoing laparoscopic surgeries requiring general anaesthesia for more than 120 minutes

Exclusion criteria

Exclusion criteria: Known allergies to propofol fentanyl or any other anaesthetics Significant cardiovascular respiratory neurological disorders or uncontrolled endocrine diseases BMI more than 40kgm2 Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
To evaluate line of agreement and expect 80 % / Performance error +/-20 % of Closed Loop Anaesthesia Delivery System with respect to measured plasma propofol concentrations obtained by reverse phase high performance liquid chromatography Timepoint: Performance error at 3 different time 5 mins after induction 30 minutes of maintainence phase 5 mins after stoping of Propofol—

Secondary

MeasureTime frame
To calculate Performance Error in plasma concentrations of propofol To calculate Median Performance Error which determines systemic bias of the predicted values To calculate Median Absolute Percentage Error To determine DivergenceTimepoint: 5 minutes after induction 30 minutes of maintenance phase 5 minutes after stopping propofol infusion—

Countries

India

Contacts

Public ContactDr Manoj Kamal

AIIMS jodhpur

geetamanoj007@yahoo.co.in6379981633

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026