Effects of earmuffs and eye masks on propofol sedation during spinal anesthesia

Effects of earmuffs and eye masks on propofol sedation during spinal anesthesia - Earmuffs and eye masks during sedation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000043496

Enrollment

Registered

2021-03-02

Start date

2021-03-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

IV sedation during spinal anesthesia for lower limb orthopedic surgery

Interventions

In the intervention group, the patients are applied with earmuffs and eye masks after proper spinal anesthesia is confirmed and IV sedation with propofol is started. In the control group, the patient

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - ASA I and II - Lower limb orthopedic surgeries - Spinal anesthesia - supine operational position

Exclusion criteria

Exclusion criteria: - General anesthesia - Combined spinal-epidural anesthesia - Patients who do not want sedation during operation - H/O allergic reaction to propofol - Lateral decubitus or prone position - Day surgery - Hearing impairment - Substance abuse - Cognitive or memory impairment

Design outcomes

Primary

Measure	Time frame
Propofol usage (mg/kg/hour)	—

Secondary

Measure	Time frame
Propofol target concentration, the time to achieve proper sedation confirmed with the BIS score under 80, spinal block level, satisfaction score about sedation during anesthesia, PCA/antiemetics usage during 24 postoperative hours	—

Countries

Asia(except Japan)

Contacts

Public ContactJin-Woo Park

Seoul National University Bundang Hospital Department of Anesthesiology and Pain Medicine

jinul8282@gmail.com82-31-787-7509

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026