NCT04752917

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

February 12, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2021

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

2.4 years

First QC Date

August 29, 2019

Last Update Submit

June 20, 2022

Conditions

AnaesthesiaKnee Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Intervention

EXPERIMENTAL

Headphones

Device: Noise Cancelling headphones

Control

NO INTERVENTION

Standard of care

Interventions

Noise Cancelling headphonesDEVICE

Use of headphones playing patients choice of music

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Deafness
  • Unwilling to use headphones
  • Unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

Study Officials

  • Richard Marks, Dr

    Sheffield Teaching Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Unblinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised trial of control and intervention groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2019

First Posted

February 12, 2021

Study Start

March 20, 2019

Primary Completion

August 24, 2021

Study Completion

August 24, 2021

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

GB(1)