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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Maulana Azad Medical College
- Enrollment
- 123
- Locations
- 1
- Primary Endpoint
- The total dose of intravenous midazolam required to maintain sedation at BIS 70-80
Study Overview
Brief Summary
We are comparing the effect of Binaural beats and Classical Neelambari Music in midazolam dose requirement for BIS guided sedation under Spinal Anesthesia In Lok Nayak Hospital Delhi. Atotal of 123 patients with 41 in each group will be enrolled for this study. Patients will be explained about the study and written informed consent will be signed.We will be using the standard Spinal Anesthesia for induction of the patients following which either of the two intervention will be applied along with 0.02mg/kg midazolam will be administered.BIS guided sedation will be assessed every 5 minutes to note the total dose of midazolam required and time to reach a BIS value 70-80. Patient satisfaction will be assessed before shifting out from PACU.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients belonging to American society of anesthesiologist Grade I and II.
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.
Outcomes
Primary Outcomes
The total dose of intravenous midazolam required to maintain sedation at BIS 70-80
Time Frame: 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 Outcomes
- Time from start of sedation to achieve BIS less than 80.(Time for BIS to return above 90 after discontinuation of midazolam.)
Investigators
Dr Zainual Abideen
Maulana Azad Medical College and associated Lok Nayak Hospital