Skip to content

Effect of noise isolation with noise-cancelling headphones during surgery on postoperative delirium and cognitive function in elderly patients with gastrointestinal malignancies: a randomized clinical trial

Effect of noise isolation with noise-cancelling headphones during surgery on postoperative delirium and cognitive function in elderly patients with gastrointestinal malignancies: a randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088102
Enrollment
Unknown
Registered
2024-08-12
Start date
2024-09-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

Postoperative delirium and cognitive function

Interventions

Noise isolation group:BIZOE noise-cancelling headphones were used for noise isolation during surgery
Blank control group:none

Sponsors

Fujian Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to No maximum

Inclusion criteria

Inclusion criteria: age > 65 years old, gender unlimited; Preoperative American society of anesthesiologists (ASA) grade I to III; Laparoscopic surgery for gastrointestinal malignancies under general anesthesia is planned; Estimated operation time > 3 hours; Patients who can correctly understand the trial process and evaluate the use of various scales, and have sufficient cognitive ability to complete the scales; Informed consent of the patient or legal representative.

Exclusion criteria

Exclusion criteria: Patients with a history of neuropsychiatric disease and cognitive dysfunction; A history of chronic narcotic drug use or alcohol abuse; Patients with hearing impairment; Requiring emergency surgery due to comorbidities (bleeding, perforation, obstruction); Known significant liver disease (Child-Pugh score B or C or presence of ascites); Renal failure (serum creatinine level =1.5 mg/dL); Obvious heart disease (ejection fraction < 50%); Significant chronic obstructive pulmonary disease (forced expiratory volume in 1 second or carbon monoxide dispersion < 50% of the expected value); Patients who are unable to communicate due to language barriers; Patients and legal representatives refuse to participate in clinical trials; Other circumstances in which the investigator determines that the subject is not suitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Incidence of delirium within 7 days after surgery;

Secondary

MeasureTime frame
The severity of postoperative delirium;Cognitive function;Postoperative recovery quality;Area under the curve of pain scores during exercise and at rest 0-72 hours after surgery;PCIA was first used after surgery as a time to press for remedial analgesia;The total amount of opioid relief analgesics converted to morphine 0-72 hours after surgery;

Countries

China

Contacts

Public ContactXuru Zhang

Fujian Cancer Hospital

609692267@qq.com+86 183 5919 2360

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026