Effect of Intraoperative Instrumental Music and Operating Room Noise Reduction on Anesthetic and Analgesic Requirements in Pediatric Patients Aged 3-18 Years Undergoing Surgery Under General Anesthesia: A Randomized Controlled Trial

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAnkara City Hospital Bilkent

About this trial

This randomized controlled clinical trial aims to evaluate the effects of intraoperative instrumental music and operating room noise reduction on anesthetic and analgesic requirements in pediatric patients aged 3-18 years undergoing elective surgery under general anesthesia.

A total of 180 patients will be randomly assigned to one of three groups: an instrumental music group, a noise reduction group, or a routine care control group. In the music group, patients will be exposed to instrumental music through headphones during surgery. In the noise reduction group, operating room noise levels will be minimized using a standardized acoustic management protocol. The control group will receive standard anesthetic care without any acoustic intervention.

All patients will undergo standardized general anesthesia. The primary outcomes will be intraoperative volatile anesthetic consumption (sevoflurane use and MAC values) and opioid requirements. Secondary outcomes will include hemodynamic parameters, postoperative pain scores, emergence delirium, and post-anesthesia care unit (PACU) length of stay.

The study does not involve any experimental drugs, invasive procedures, or additional risks beyond routine clinical care. The findings may help determine whether simple non-pharmacological acoustic interventions can reduce anesthetic and analgesic requirements and improve perioperative outcomes in pediatric patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

The study population will consist of pediatric patients aged 3 to 18 years who are scheduled to undergo elective surgical procedures under general anesthesia at a tertiary care university-affiliated hospital. Eligible participants will have ASA physical status I or II and will be recruited during the preoperative evaluation period. Patients undergoing emergency surgery or presenting with conditions that may interfere with the study interventions or outcome assessments will be excluded.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

180 Participants
are grouped into 3 trial groups
Group A: Instrumental Music Group
Group B: Noise Reduction Group
Group C: Routine Care Control Group

Trial outcomes

Primary outcomes

1

Intraoperative Sevoflurane Consumption

Total intraoperative sevoflurane consumption will be measured using average MAC values and total volatile anesthetic consumption recorded by the anesthesia machine during the surgical procedure.

Time frame
From induction of anesthesia until completion of surgery (up to 4 hours)
2

Intraoperative Anesthetic and Opioid Consumption

Total intraoperative sevoflurane consumption and opioid requirement will be recorded throughout the surgical procedure. Sevoflurane consumption will be assessed using average MAC values and total volatile anesthetic use recorded by the anesthesia machine. Opioid requirement will be assessed as the total intraoperative opioid dose administered per kilogram of body weight. Outcomes will be compared among the instrumental music, noise reduction, and routine care groups.

Time frame
From induction of anesthesia until completion of surgery (up to 4 hours)

Secondary outcomes

1

Intraoperative Sevoflurane Consumption

Total intraoperative sevoflurane consumption will be measured using average minimum alveolar concentration (MAC) values and total volatile anesthetic consumption recorded by the anesthesia machine throughout the surgical procedure.

Time frame
From induction of anesthesia until completion of surgery (up to 4 hours)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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