General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement
Conditions
Keywords
Pediatric Anesthesia, General Anesthesia, Instrumental Music
Brief summary
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.
Detailed description
This study is a prospective, single-center, three-arm randomized controlled trial including pediatric patients aged 3-18 years who are scheduled for elective surgery under general anesthesia. Participants will be randomly assigned to one of three groups: intraoperative instrumental music, operating room noise reduction, or routine care. In the music group, instrumental music will be delivered through headphones during surgery. In the noise reduction group, operating room noise will be minimized using a standardized acoustic management approach. The routine care group will receive standard anesthesia care without an additional acoustic intervention. General anesthesia will be managed according to a standardized protocol. Anesthetic depth, hemodynamic variables, anesthetic consumption, opioid use, postoperative pain, emergence delirium, and recovery room stay will be recorded and compared between groups. The study is designed to investigate whether simple non-pharmacological acoustic interventions during surgery can reduce anesthetic and analgesic requirements and improve early postoperative recovery in children.
Interventions
None listed
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Children aged 3 to 18 years Scheduled for elective surgery under general anesthesia American Society of Anesthesiologists (ASA) physical status I or II Expected surgical duration between 30 minutes and 4 hours Eligibility for standardized general anesthesia management No contraindication to the use of headphones or acoustic interventions Written informed consent obtained from a parent or legal guardian Assent obtained from children when appropriate according to age and cognitive capacity -
Exclusion criteria
Emergency surgery ASA physical status III or higher Significant neurological disorders or developmental delay Severe cognitive impairment preventing appropriate assessment Epilepsy or disorders associated with increased sensitivity to auditory stimulation Moderate to severe hearing impairment or active ear disease Chronic use of opioids, sedatives, or psychoactive medications Severe cardiac, hepatic, or renal dysfunction Refusal of participation by the parent, legal guardian, or patient \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Sevoflurane Consumption | From induction of anesthesia until completion of surgery (up to 4 hours) | 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. |
| Intraoperative Anesthetic and Opioid Consumption | From induction of anesthesia until completion of surgery (up to 4 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Sevoflurane Consumption | From induction of anesthesia until completion of surgery (up to 4 hours) | 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. |
Outcome results
None listed