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

NCT07630675 | Not Yet Recruiting

• 2 other identifiers: E. Kurul-E2-26-14703TABED 1-26-2457
• Study Type: observational
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

General Anesthesia; Pediatric Surgery; Intraoperative Music Therapy; Operating Room Noise Reduction; Anesthetic Requirement; Analgesic Requirement

Keywords

Pediatric Anesthesia; General Anesthesia; Instrumental Music

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Intraoperative Sevoflurane Consumption

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

Study Arms (3)

Instrumental Music Group

Participants randomized to this group will receive instrumental music through headphones during surgery under general anesthesia. Music playback will begin after induction of anesthesia and continue throughout the surgical procedure. Standard anesthesia management will be maintained for all participants.

Noise Reduction Group

Participants randomized to this group will undergo surgery under general anesthesia in an operating room where environmental noise is minimized using a standardized noise reduction protocol. Standard anesthesia management will be maintained for all participants.

Routine Care Control Group

Participants randomized to this group will receive standard perioperative care and general anesthesia without any additional acoustic intervention, music exposure, or noise reduction measures.

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study 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.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 5, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-05