A study of auditory stimulation effects on emergence from general anesthesia

JRCT ID: jRCT1050240251

Registered date:28/01/2025

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Patients undergoing knee osteoarthritis surgery under general anesthesia
• Date of first enrollment: 28/01/2025
• Target sample size: 80
• Study type: Interventional

Intervention(s)

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. Please open your eyes." After the patient emerges from anesthesia, the voice continues, "Please take slow, deep breaths. Open your mouth wide as we remove your breathing tube." The auditory stimuli are calibrated to a volume consistent with normal speech, ranging from 50 to 60 dB, and are repeated at 10-second intervals. Once extubation is complete, the headphones are removed, concluding the intervention.
For patients in the female voice group, the same procedure is followed using a pre-recorded female voice.

Outcome(s)

• Primary Outcome: Time from the end of anesthetic administration to the emergence of the patient

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Sakamoto Haruka