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Effect of 40Hz Gamma Wave Auditory Stimulation During Surgery on Postoperative Delirium in Elderly Patients Undergoing Major Non-cardiac Surgery: A Prospective, Parallel-Group, Randomized Controlled Tria

Effect of 40Hz Gamma Wave Auditory Stimulation During Surgery on Postoperative Delirium in Elderly Patients Undergoing Major Non-cardiac Surgery: A Prospective, Parallel-Group, Randomized Controlled Tria

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115156
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-23
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Postoperative delirium

Interventions

Group A:wear headphones that do not play 40Hz ?-wave sounds after successful induction of anesthesia
Group B:wear headphones that play 40Hz ?-wave sounds for 2 hours after successful induction of anesthesia

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 65 years old; 2. Intending to undergo general anesthesia with tracheal intubation for major surgery (Major surgery is defined as any surgical procedure where the time from the incision to skin suturing is expected to exceed 2 hours, and the expected postoperative hospital stay is at least 3 days.); 3. ASA classification I–III; 4. Intending to be hospitalized for more than 72 hours after the surgery.

Exclusion criteria

Exclusion criteria: 1. Refusal to participate; 2. Emergency surgery or trauma patients; 3. Mini-Mental State Examination (MMSE) score <= 23; 4. Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia; 5. Illiterate, language disorder or significant hearing or vision impairment, unable to communicate verbally; 6. Liver function Child-Pugh grade C, severe liver dysfunction; 7. Severe renal insufficiency, requiring preoperative renal replacement therapy; 8. History of intraoperative awareness in the past; 9. Having fallen at least once in the past 6 months; 10. Long-term use of antidepressants, psychotropic drugs and recent history of drug abuse; 11. Unable to wear headphones due to auricle deformity; 12. Participants who have participated in other clinical trials within the past 4 weeks; 13. Patients with contraindications or allergic history to the drugs used in the research protocol.

Design outcomes

Primary

MeasureTime frame
The incidence of Postoperative Delirium (POD );

Secondary

MeasureTime frame
The severity of Postoperative Delirium (POD );AIS scores postoperatively ;Pain scores at rest and while coughing;The incidence of postoperative nausea and vomiting (PONV) ;Length of postoperative hospital stay;Post-anesthesia Care Unit (PACU) stay time;Quality of postoperative recovery;All-cause mortality rate after surgery;Incidence of perioperative adverse events;a composite variable of major Major postoperative complications;Postoperative analgesic use;rescue antiemetics usage;EuroQol 5 Dimensions 5 Levels after surgery;

Countries

China

Contacts

Public ContactLiu Huayue

The First Affiliated Hospital of Soochow University

docliu.hy@suda.edu.cn+86 153 6538 8833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 11, 2026