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Effect of noise cancellation and propofol dose

Effect of noise cancellation on the induction dose of propofol using closed-loop anaesthesia delivery system in patients presenting for non-cardiac surgeries: prospective randomized non-inferiority clinical trail. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077838
Enrollment
100
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Noise cancelling headphones: Closed loop anesthesia delivery system with noise cancelling headphones with active noise cancellation, removing about 20 dB of noise from the surroundings.

Sponsors

Dr Karthickeyan
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: patients who have given consent ASA 1 and 2

Exclusion criteria

Exclusion criteria: Patients who denied consent ASA 3, 4, 5. Head and neck surgeries (inability to used BIS/EEG feedback) Known hearing loss

Design outcomes

Primary

MeasureTime frame
Difference in the propofol dose required to achieve BIS 50 in adults presenting for elective non-cardiac surgeries when active noise cancellation is provided versus when it is not as part of CLADS based inductionTimepoint: at the end of induction (first instance of BIS 50)

Secondary

MeasureTime frame
Estimated effect site concentration of propofol at induction Timepoint: at the end of induction (first instance oF BIS 50);Time to achieve BIS-50 on induction Timepoint: time from start of induction at BIS 100 to BIS 50;Total intraoperative dose of propofol (mg/kg/hr) Timepoint: propofol dose used from starting of induction to the end of surgery;Frequency of post induction hypotension Timepoint: till 10 minutes after induction;Rescue dose of phenylephrine and mephentermine used Timepoint: from induction to end of surgery;Percentage of time spent between BIS 40-60Timepoint: from induction to stopping propofol;Recovery timeTimepoint: stop of infusion to extubation;PONV scores Timepoint: at 30 mins,6th, 12th, 24th hour postopearatively;Postoperative NRS pain scoresTimepoint: at 30 mins, 6th, 12th, 24th hour of postoperative period;Postoperative deliriumTimepoint: at 30 mins, 6th, 12th, 24th hour postoperatively

Countries

India

Contacts

Public ContactDr Venkata Ganesh

Post Graduate Institute of Medical Education and Research

bjfiero@gmail.com8427561868

Outcome results

None listed

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