Do Noise Cancelling Headphones Reduce Sedation Requirements in Primary Knee Arthoplasty (NOISE)

Do Noise Cancelling Headphones Reduce Patient Controlled Midazolam Requirements in Primary Knee Arthroplasty Patients Under Spinal Anaesthesia

The study is a randomised trial of headphones with midazolam patient controlled sedation (intervention group) vs control group with no heaphones to compare sedation usage during knee replacement surgery under spinal.

The trial is a pilot study of 20 cases

Study Overview

• Status: Terminated
• Conditions: Anaesthesia; Knee Surgery
• Intervention / Treatment: Device: Noise Cancelling headphones

Detailed Description

The study is for patients undergoing elective primary knee replacement surgery under spinal anaesthesia. It is proposed that using music played on noise cancelling headphones will reduce the requirements for intravenous sedation in a randomised controlled trial of twenty patients. Spinal anaesthesia is commonly used for knee replacement. It provides loss of feeling from the operated limb but the patient remains awake. Orthopaedic surgery is very noisy. It is usual for patients to receive intravenous sedation with midazolam to reduce their awareness of surgery. Intravenous midazolam is effective but it depresses both the breathing and the circulation and may cause low blood pressure and reduced oxygenation. It is expected that by using noise cancelling headphones to reduce the awareness of noise during surgery, there will be a reduced requirement for intravenous midazolam. The study will measure the dose of midazolam required by patients randomised to receive either noise cancelling headphones playing music (intervention) or no headphones (control group). Patients will be followed up prior to hospital discharge to assess their awareness and recall of intra operative events and their satisfaction with intravenous sedation. This is a novel application of sound reducing technology capable of improving the patient experience during surgery whilst potentially reducing complications of intravenous midazolam sedation. Noise cancelling technology is readily available in commercially available headphones and it has the potential to eliminate background noise of surgical procedures. This study findings will be of interest for health professionals and patients involved in surgery or investigative procedures normally carried out with intravenous sedation.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7AU
      • Sheffield Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elective primary knee surgery under spinal anaesthesia
• Willing to receive patient controlled midazolam sedation

Exclusion Criteria:

• Deafness
• Unwilling to use headphones
• Unable to consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard of care
Experimental: Intervention; Headphones	Device: Noise Cancelling headphones; Use of headphones playing patients choice of music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of sedation requirements during elective orthopaedic surgery.	Measuring the difference in intravenous sedation requirements for patient controlled midazolam during elective primary knee joint replacement surgery.	3 hours

Collaborators and Investigators

• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Richard Marks, Dr, Sheffield Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2019
• Primary Completion (Actual): August 24, 2021
• Study Completion (Actual): August 24, 2021

Study Registration Dates

• First Submitted: August 29, 2019
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: STH20161

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: This is pilot data and will hopefully lead to an application for a larger definitive study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No