Do Noise Cancelling Headphones Reduce Sedation Requirements in Primary Knee Arthoplasty

NCT ID: NCT04752917

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-20
• Study Completion Date: 2021-08-24

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.

Conditions

Anaesthesia; Knee Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention

Headphones

Group Type: EXPERIMENTAL

Noise Cancelling headphones

Intervention Type: DEVICE

Use of headphones playing patients choice of music

Control

Standard of care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Noise Cancelling headphones

Use of headphones playing patients choice of music

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Marks, Dr

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

STH20161

Identifier Type: -

Identifier Source: org_study_id