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Evaluation of computer controlled anaesthesia in multiple centres in India

Multi-centric evaluation of Closed Loop Anaesthesia Delivering System (CLADS-1)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000041
Enrollment
200
Registered
2010-09-30
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Adult patients to undergo non-thoracic / nonvascular / non-neurosurgical major surgical procedure of expected duration of 1-3 hours

Interventions

Intervention1: Anaesthesiologist controlled anaesthesia using feedback from BIS.: Computer controlled anaesthesia using closed loop anaesthesia delivery system (CLADS) using feedback from bispectral i

Sponsors

Dr GD Puri
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult males or females without prior significant cardiorespiratory illness and aged between 18 and 60 years of age scheduled to undergo non-thoracic / nonvascular / nonneurosurgical major surgical procedure of expected duration of 1-3 hours

Exclusion criteria

Exclusion criteria: Patient weighing <70% or >130% ideal bodyweight, those with neurological disorder and those who use psychoactive drugs including alcohol

Design outcomes

Primary

MeasureTime frame
Performance assessment of bispectral index 1. Percentage of total anaesthesia time BIS remained within 10% of target BIS 2. Median absolute performance error 3. Wobble 4. Divergence Timepoint: During anaesthesia

Secondary

MeasureTime frame
Haemodynamic performance during anaesthesia 1. Percentage of anaesthesia time the heart rate was within 25% of the baseline 2. Percentage of anaesthesia time the mean arterial pressure was within 25% of the baseline Timepoint: Intra-op

Countries

India

Contacts

Public ContactDr Preethy J Mathew

PGIMER

gdpuri007@hotmail.com9914209509

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026