RecruitingNot ApplicableNCT06918470

Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain

Research on the Effect of Noise Cancelling Headphones in Reducing Postoperative Pain During Gynecological Laparoscopic Surgery ：a Randomized Controlled Trial

Sponsor

Maternal and Child Health Hospital of Hubei Province

Enrollment

300 participants

Start Date

Feb 12, 2025

Study Type

INTERVENTIONAL

Conditions

Postoperative Pain Noise Cancelling Headphones

Summary

this randomized controlled trial selects patients undergoing gynecological laparoscopy under general anesthesia. By using noise reduction earphones during surgery, the patient's postoperative pain score and demand for opioids are observed, providing a basis and reference for the efficacy and safety of noise reduction earphones in gynecological endoscopic surgery.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Inclusion Criteria1

ASA grade I or II, aged 18-55 years , female were selected for gynecological laparoscopy under elective general anesthesia. -

Exclusion Criteria2

History of serious illness requiring further care in the intensive care unit after surgery; Abnormal hearing; Postoperative mechanical ventilation or continued anesthesia or sedation is required; Preoperative chronic pain or long-term use of painkillers; other factors that hinder patients from cooperating with the research plan
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Interventions

OTHERStandard monitoring techniques

（3）atients were given the same anesthesia regimen. Standard monitoring techniques include electrocardiogram, pulse oximeter, heart rate and blood pressure monitoring, continuous monitoring of bispecific index of electroencephalography, and the use of remifentanil (0.3 mg/kg) Rapid sequence induction was performed using sufentanil (0.3 μ g/kg), propofol (2.5mg/kg), and rocuronium bromide (0.6 mg/kg). Anesthesia was maintained using remifentanil (0.1-0.2 μ g/0kg/min), inhaled sevoflurane (1%), and intravenous propofol (1-4 mg/kg/h) to maintain BIS 40-60, with heart rate and blood pressure within 20% of baseline values.

OTHERnoise cancelling headphones

The treatment group started wearing noise cancelling headphones until the end of the surgery in the general anesthesia induction group to isolate intraoperative environmental noise,patients were given the same anesthesia regimen. Standard monitoring techniques include electrocardiogram, pulse oximeter, heart rate and blood pressure monitoring, continuous monitoring of bispecific index of electroencephalography, and the use of remifentanil (0.3 mg/kg) Rapid sequence induction was performed using sufentanil (0.3 μ g/kg), propofol (2.5mg/kg), and rocuronium bromide (0.6 mg/kg). Anesthesia was maintained using remifentanil (0.1-0.2 μ g/0kg/min), inhaled sevoflurane (1%), and intravenous propofol (1-4 mg/kg/h) to maintain BIS 40-60, with heart rate and blood pressure within 20% of baseline values.