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How listening music can affect the amount of sedation drug needed during spinal anaesthesia

Comparative evaluation of the effect of binaural beats and classical music on midazolam requirement for Bispectral index(BIS) guided sedation during spinal anaesthesia:A Randomised controlled study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094112
Enrollment
123
Registered
2025-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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: O- Medical and Surgical

Interventions

Intervention1: Binaural Beats Music: A noise cancelling headphones will be given to the patient Binaural Beats will be played to aid in midazolam sedation during spinal anesthesia Intervention2: Class

Sponsors

Maulana Azad Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to American society of anesthesiologist Grade I and II

Exclusion criteria

Exclusion criteria: Pregnant patients Bleeding or coagulation abnormality Local skin infection at the site of spinal block History of OSA Inability to understand the procedure Hearing impairment BMI more than equal to 35 kg per metre square Surgery in prone position

Design outcomes

Primary

MeasureTime frame
The total dose of intravenous midazolam required to maintain sedation at BIS 70-80Timepoint: BIS at baseline Midazolam first dose at baseline Midazolam subsequent doses,if required, after every five minutes. time to start midazolam infusion at the end of 2 hrs

Secondary

MeasureTime frame
Time from start of sedation to achieve BIS less than 80. Time for BIS to return above 90 after discontinuation of midazolam. Patient satisfaction score at the time of shifting from Post Anaesthesia Care UnitTimepoint: Every 10 minutes At the end of surgery Before shifting to PACU

Countries

India

Contacts

Public ContactDr Lalit Gupta

Maulana Azad Medical College and associated Lok Nayak Hospital

lalit.doc@gmail.com9868092739

Outcome results

None listed

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