Do Noise Cancelling Headphones Reduce Sedation Requirements in Primary Knee Arthoplasty

Not Applicable

Terminated

• Conditions: Anaesthesia; Knee Surgery
• Interventions: Device: Noise Cancelling headphones

• Registration Number: NCT04752917
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

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.

Study Timeline

• Study Start: 2019-03-20
• Study First Submitted: 2019-08-29
• Study First Submitted QC: 2021-02-09
• Study First Posted: 2021-02-12
• Primary Completion: 2021-08-24
• Study Completion: 2021-08-24
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Noise Cancelling headphones	Headphones

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom