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Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynaecological laparoscopic surgery: a single center, prospective, andomised controlled study

Effect of intraoperative noise isolation on postoperative nausea and vomiting in patients undergoing gynaecological laparoscopic surgery: a single center, prospective, andomised controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087460
Enrollment
Unknown
Registered
2024-07-29
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

postoperative nausea and vomiting

Interventions

Control group:None
Noise Reduction group:Wearing noise-cancelling headphones (3MTM PeltorTM X5A acoustic noise-cancelling earmuffs)

Sponsors

The First Affiliated Hospital of Soochow University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Female patients aged 18-65 years; 2) ASA physical status I to II; 3) Laparoscopic gynaecological surgery under general anaesthesia with an estimated operative time more than 30 minutes;

Exclusion criteria

Exclusion criteria: 1) Pregnant and breastfeeding patients; 2) History of cancer chemotherapy; 3) Average thresholds >40 dB at four frequency points: 500, 1000, 2000, 4000, 6000, 8000 Hz on pure tone audiometry (PTA); 4) Comorbidities known to increase the risk of PONV: e.g. impaired gastric motility and vestibular disease; 5) Liver or renal dysfunction (ChildPugh class C or renal replacement therapy); 6) Long-term history of sedative, antidepressant or psychoactive drug abuse, history of alcoholism, etc; 7) History of central nervous system disease, psychiatric disease or speech communication disorder; 8) Using antiemetic and psychotropic drugs or glucocorticoids within 24 hours before surgery; 9) Unable to wear headphones due to auricular deformity or other reasons; 10) Hypersensitivity to study medication.

Design outcomes

Primary

MeasureTime frame
incidence of postoperative nausea and vomiting (PONV);

Secondary

MeasureTime frame
the severity of PONV;antiemetic rescue therapy;pain scores at rest and while coughing;need for rescue analgesia;Quality of postoperative recovery;Postoperative sleep quality;adverse effects related to anesthetics (hypertension, hypotension, tachycardia, bradycardia, postextubation low oxygen saturation, chills, awakening agitation, excessive sedation, severe arrhythmia, cardiac arrest, hypothermia);length of PACU stay;time to extubation;length of postoperative hospital stay; patient satisfaction;a composite variable of major Major postoperative complications;

Countries

China

Contacts

Public ContactLiu Huayue

The First Affiliated Hospital of Soochow University

docliu.hy@163.com+86 153 6538 8833

Outcome results

None listed

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