Noise Cancelling Headphones, Postoperative Pain
Conditions
Brief 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.
Detailed description
Every year, 200 million surgical procedures are performed worldwide, and 40-65% of patients experience moderate to severe pain after surgery Failure to provide sufficient postoperative analgesia increases the risk of surgical complications and affects patients' early activity and recovery . Opioids are still the main method of treatment, and their side effects include urinary retention, itching, nausea, vomiting, postoperative intestinal obstruction, dizziness and cognitive impairment . Researchers pay more and more attention to non pharmacology and non-invasive analgesia methods, including music therapy, traditional Chinese medicine acupuncture and moxibustion and watching educational videos . Due to the introduction of various surgical tools, the noise pollution in the operating room has gradually intensified, affecting surgical patients and medical staff. Previous studies have shown that general anesthesia does not hinder the brain's processing ability for sound and language; The patient's auditory cortex remains active , and even in anesthesia induced coma, the patient can still maintain the ability to understand auditory information. Other recent studies have found that intraoperative exposure to positive auditory stimuli, including music, treatment suggestions and white noise, can reduce postoperative pain, environmental protection, and acupuncture and moxibustion can also have a similar positive impact . Therefore, 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.
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.
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.
Sponsors
Maternal and Child Health Hospital of Hubei Province
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
ASA grade I or II, aged 18-55 years , female were selected for gynecological laparoscopy under elective general anesthesia. -
Exclusion criteria
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain scores | 6, 12, and 24 hours postoperatively | the patient's resting and exercise induced pain scores,by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled no pain (0) and worst pain imaginable (10). |
| maximum pain scores | at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively. | maximum pain scores at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled no pain (0) and worst pain imaginable (10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum resting pain score | within 24 hours postoperatively | by the Visual Analog Scale (VAS) It typically involves a 10-centimeter horizontal or vertical line, with endpoints labeled no pain (0) and worst pain imaginable (10). |
| total opioid consumption | within 24 hours postoperatively | — |
| the number of PCIA pump buttons | within 24 hours postoperatively | — |
Countries
China
Contacts
Primary ContactNa Li, MD
Outcome results
None listed