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A study of auditory stimulation effects on emergence from general anesthesia

A study of auditory stimulation effects on emergence from general anesthesia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1050240251
Enrollment
80
Registered
2025-01-28
Start date
2025-06-17
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

Patients undergoing knee osteoarthritis surgery under general anesthesia

Interventions

Following the cessation of anesthetic infusion, a pre-recorded male voice is played through noise-cancelling headphones for patients in the male voice group. The message states, "Surgery is over. Plea

Sponsors

Sakamoto(Kida) Haruka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients undergoing knee osteoarthritis surgery under general anesthesia at North Medical Center Kyoto Prefectural University of Medicine, or Fukuchiyama City Hospital. Patients aged over 65 years at the time of surgery. Patients with an ASA physical status (PS) classification of 1 or 2. Patients who have provided informed consent to participate in the study.

Exclusion criteria

Exclusion criteria: Patients who cannot speak Japanese Patients with obvious hearing loss Patients with severe liver dysfunction (Child-Pugh score B or C) Patients with renal dysfunction (serum creatinine levels >=4.0 mg/dL) Patients with obesity (BMI >=35) Patients with symptomatic neurological disorders Patients who regularly use psychotropic drugs Patients with alcohol dependence or abuse Patients with allergies to the study drugs

Design outcomes

Primary

MeasureTime frame
Time from the end of anesthetic administration to the emergence of the patient

Secondary

MeasureTime frame
Time from the end of anesthetic administration to BIS values of 60, 70, and 80 Time from the end of anesthetic administration to extubation and discharge from the operating room Blood pressure and heart rate at the time of anesthetic cessation, when BIS value >70, at emergence, at extubation, and upon discharge from the operating room BIS value at the time of anesthetic cessation Predicted effect-site concentrations and plasma concentrations of propofol and remifentanil at the time of anesthetic cessation Predicted effect-site concentrations and plasma concentrations of propofol at the time of induction and emergence Riker Sedation-Agitation Scale scores from emergence to discharge The pain score (using the Numerical Rating Scale) and the presence or absence of nausea and vomiting upon return to the general ward The pain score (using the Numerical Rating Scale) and the presence or absence of nausea and vomiting on the following day

Contacts

Public ContactHaruka Sakamoto(Kida)

Kyoto Prefectural University of Medicine

kidah@koto.kpu-m.ac.jp+81-75-251-5633

Outcome results

None listed

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