Therapeutic advances in drug safety · 2024
Comparison of a single intravenous infusion of alfentanil or sufentanil combined with target-controlled infusion of propofol for daytime hysteroscopy: a randomized clinical trial.
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Lei Xiaofeng, Zhang Tinghuan, Huang Xuezhu
Аннотация
BACKGROUND: The administration of either alfentanil or sufentanil as a single injection, combined with target-controlled infusion (TCI) of propofol, represents a frequently employed anesthetic regimen for daytime hysteroscopy.
OBJECTIVES: This study was designed to evaluate and compare the safety and efficacy of alfentanil and sufentanil in the context of daytime hysteroscopy.
DESIGN: A total of 160 patients, scheduled for daytime hysteroscopy, were randomly allocated into two groups: Group A and Group S respectively received alfentanil 10 μg/kg or sufentanil 0.15 μg/kg as a single intravenous injection. Both groups were given propofol with TCI for sedation.
METHODS: Monitoring of vital signs was conducted from pre-anesthesia through to 2 h postoperatively. The primary outcome measured was hypoxemia, defined as SpO2 levels below 92% for a duration of 30 s, which necessitated manual positive pressure ventilation. Secondary outcomes included various perioperative complications, such as postoperative nausea and vomiting (PONV) occurring 2 h after surgery, as well as hemodynamic indicators, NRS scores for pain, and other anesthesia-related data. This comprehensive dataset was meticulously documented and subsequently analyzed for comparative purposes.
RESULTS: The analyses revealed that Group A had a significantly lower incidence of hypoxemia (p = 0.002) and PONV (p = 0.021). Additionally, group A demonstrated overall more stable blood pressure and heart rate, as well as higher SpO2 levels.
CONCLUSION: For daytime hysteroscopy, alfentanil at a dose of 10 μg/kg is safer than sufentanil at a dose of 0.15 μg/kg when combined with propofol TCI.
TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry (The URL of registration is https://www.chictr.org.cn/showproj.html?proj=177784; registration number: ChiCTR2200063939). The date of first registration was September 21, 2022.
OBJECTIVES: This study was designed to evaluate and compare the safety and efficacy of alfentanil and sufentanil in the context of daytime hysteroscopy.
DESIGN: A total of 160 patients, scheduled for daytime hysteroscopy, were randomly allocated into two groups: Group A and Group S respectively received alfentanil 10 μg/kg or sufentanil 0.15 μg/kg as a single intravenous injection. Both groups were given propofol with TCI for sedation.
METHODS: Monitoring of vital signs was conducted from pre-anesthesia through to 2 h postoperatively. The primary outcome measured was hypoxemia, defined as SpO2 levels below 92% for a duration of 30 s, which necessitated manual positive pressure ventilation. Secondary outcomes included various perioperative complications, such as postoperative nausea and vomiting (PONV) occurring 2 h after surgery, as well as hemodynamic indicators, NRS scores for pain, and other anesthesia-related data. This comprehensive dataset was meticulously documented and subsequently analyzed for comparative purposes.
RESULTS: The analyses revealed that Group A had a significantly lower incidence of hypoxemia (p = 0.002) and PONV (p = 0.021). Additionally, group A demonstrated overall more stable blood pressure and heart rate, as well as higher SpO2 levels.
CONCLUSION: For daytime hysteroscopy, alfentanil at a dose of 10 μg/kg is safer than sufentanil at a dose of 0.15 μg/kg when combined with propofol TCI.
TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry (The URL of registration is https://www.chictr.org.cn/showproj.html?proj=177784; registration number: ChiCTR2200063939). The date of first registration was September 21, 2022.