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Effect of Operating Room Noise on BIS and Hemodynamics Under General Anesthesia

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later across 2 updates May 30, 2026 → Dec 30, 2026
See other at-risk trials from Başakşehir Çam & Sakura City Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened Show 8 more changesShow less
    • Lead sponsor: Başakşehir Çam & Sakura City Hospital to Başakşehir Çam & Sakura City Hospital
    • Primary completion pushed from Nov 30, 2026 to Dec 30, 2026
    • Study completion pushed from Dec 1, 2026 to Jan 30, 2027
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 1, 2026 to Sep 1, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 3 entries
    • Publications: details revised at 4 of 4 entries
  2. Notable Primary completion pushed from May 30, 2026 to Nov 30, 2026
    • Start date: Feb 1, 2026 to Aug 1, 2026
    • Study completion pushed from Jun 1, 2026 to Dec 1, 2026
    v3
  3. Notable Start date: Oct 1, 2025 to Feb 1, 2026
    • Primary completion date: Apr 30, 2026 to May 30, 2026
    • Study completion date: May 1, 2026 to Jun 1, 2026
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This prospective observational study aims to evaluate the impact of operating room noise on bispectral index (BIS) and hemodynamic parameters in patients undergoing general anesthesia. Environmental noise in operating rooms, often overlooked, may influence anesthesia depth, patient safety, and physiological stability. A total of 70 adult patients (ASA I-II, 18-65 years, elective surgery under general anesthesia) will be enrolled at Başakşehir Çam and Sakura City Hospital. Patients will be categorized into two groups based on intraoperative average noise levels: noisy group (\>65 dB) and quiet group (\<55 dB). Noise levels will be measured every 10 minutes using a CEM DT-8850 sound level meter, BIS will be recorded every 10 minutes, and hemodynamic variables (systolic, diastolic, mean arterial pressure, and heart rate) will be recorded every 5 minutes. Primary outcome is the correlation between mean intraoperative noise levels (LAeq) and BIS values during the maintenance phase of anesthesia. Secondary outcomes include the relationship between noise characteristics (e.g., device-related, human-related, alarms, media) and hemodynamic stability, as well as surgical branch-related noise classifications (high, moderate, low). The study is non-interventional, with no additional risk to participants beyond standard clinical monitoring. Findings are expected to provide evidence on the role of environmental noise in anesthesia quality, inform operating room organization, and contribute to patient safety improvements.
Trial Details
NCT Number NCT07194707
Lead Sponsor Başakşehir Çam & Sakura City Hospital
Conditions
(from sponsor)
General Anesthesia, Hemodynamics, Noise Exposure
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov