NCT06918470|RecruitingDMC
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Sponsor study identifier
interventional
300
1 country
1
Study Start
February 12, 2025
Actual (reported)Primary Completion
May 12, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 12, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 12, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 12, 2025
Actual (reported)March 28, 2025
Actual (reported)April 9, 2025
Actual (reported)May 12, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 12, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
pain scores
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).
6, 12, and 24 hours postoperatively
maximum pain scores
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).
at 0-6 hours, 6-12 hours, and 12-24 hours postoperatively.
maximum resting pain score
within 24 hours postoperatively
total opioid consumption
within 24 hours postoperatively
the number of PCIA pump buttons
within 24 hours postoperatively
Standard monitoring techniques ,Conventional processing without noise cancelling headphones
group started wearing noise cancelling headphones until the end of the surgery in the general anesthesia induction group to isolate intraoperative environmental noise
（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.
Maternal and Child Health Hospital of Hubei Province,
Wuhan, Hubei, 430000, China
Na Li, MD
Maternal and Child Health Hospital of Hubei Province
First Submitted
March 28, 2025
First Posted
April 9, 2025
Study Start
February 12, 2025
Actual (reported)Primary Completion
May 12, 2025
Estimated (date passed)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.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 12, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 9, 2025
Record last verified: 2025-03
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