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The Effectiveness of Binaural Beats on Midazolam Requirement During Cesarean Section With Spinal Anesthesia
Sponsor study identifier
interventional
200
0 countries
N/A
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Spinal anesthesia is the most commonly used anesthetic technique for cesarean section in developed countries, but vasodilation and a decrease in systemic vascular resistance caused by sympathetic blockade result in hypotension in 7-74% of parturients. The fetus receives oxygen from the mother via uteroplacental blood flow, and because uteroplacental circulation during pregnancy has minimal autoregulation, uterine blood flow changes in proportion to maternal blood pressure. Therefore, a reduction in uterine blood flow due to maternal hypotension can lead to fetal hypoxia or acidosis and is associated with low Apgar scores after birth. Oxygen administration may offer potential benefits, such as improving maternal cerebral perfusion and preventing fetal ischemic injury, and thus low-flow oxygen via a conventional nasal cannula is commonly used. However, there are few studies evaluating the effects of high-flow oxygen administration on fetal well-being during cesarean section under spinal anesthesia. Low-flow oxygen delivery through a conventional nasal cannula, which is commonly used during cesarean section under spinal anesthesia, results in a fraction of inspired oxygen (FiO₂) of less than 40% due to dilution with ambient air. In contrast, OptiFlow THRIVE (Fisher and Paykel Healthcare, Panmure, Auckland, New Zealand) is a device capable of delivering high-flow oxygen through a nasal interface, allowing administration of 100% oxygen to the mother and potentially providing greater protection against fetal ischemic injury. Delivering non-humidified oxygen at flow rates above 10 L/min causes significant discomfort in awake patients, but OptiFlow THRIVE passes the gas through a heated humidification chamber immediately before delivery, enabling the administration of warmed and humidified oxygen even at high flow rates. Therefore, this study aims to compare high-flow nasal cannula oxygen therapy initiated upon operating room admission with conventional low-flow nasal cannula oxygen therapy during cesarean section under spinal anesthesia, assessing their effects on maternal hemodynamic parameters and, ultimately, on fetal acid-base status.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2027
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.
March 31, 2026
Actual (reported)April 7, 2026
Actual (reported)April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
umbilical arterial base deficit measured immediately after birth.
The attending obstetrician will obtain an umbilical arterial blood sample using a needle immediately after birth (immediately after umbilical cord clamping).
Immediately after birth (i.e., approximately 1 minute after umbilical cord clamping)
The group receiving oxygen via a high-flow nasal cannula
The group receiving oxygen via a conventional nasal cannula
All patients will, upon admission to the operating room, be placed in the supine position and connected to standard monitoring. Once patient monitoring has been completed, patients in the high-flow nasal cannula oxygen group will receive 100% oxygen at 50 L/min via OptiFlow THRIVE. Thereafter, patients will be placed in the left lateral decubitus position, and spinal anesthesia will be performed at the lower lumbar level.
First Submitted
March 31, 2026
First Posted
April 7, 2026
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
March 31, 2027
EstimatedAll patients will, upon admission to the operating room, be placed in the supine position and connected to standard monitoring. Once patient monitoring has been completed, patients in the conventional nasal cannula oxygen group will receive oxygen at 2 L/min via a nasal cannula. Thereafter, patients will be placed in the left lateral decubitus position, and spinal anesthesia will be performed at the lower lumbar level.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2026
Record last verified: 2026-03
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Source: ClinicalTrials.gov.
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