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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04752917
Other study ID # STH20161
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date March 20, 2019
Est. completion date August 24, 2021

Study information

Verified date June 2022
Source Sheffield Teaching Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 9
Est. completion date August 24, 2021
Est. primary completion date August 24, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
Noise Cancelling headphones
Use of headphones playing patients choice of music

Locations

Country Name City State
United Kingdom Sheffield Teaching Hospitals NHS Foundation Trust Sheffield South Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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