Skip to content

Do Noise Cancelling Headphones Reduce Sedation Requirements in Primary Knee Arthoplasty

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04752917
Acronym
NOISE
Enrollment
9
Registered
2021-02-12
Start date
2019-03-20
Completion date
2021-08-24
Last updated
2022-06-24

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

Conditions

Anaesthesia, Knee Surgery

Brief summary

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

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.

Interventions

Use of headphones playing patients choice of music

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Unblinded

Intervention model description

Randomised trial of control and intervention groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change of sedation requirements during elective orthopaedic surgery.3 hoursMeasuring the difference in intravenous sedation requirements for patient controlled midazolam during elective primary knee joint replacement surgery.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026