Skip to Main Content
 

Global Search Box

 
 
 
 

Files

ETD Abstract Container

Abstract Header

A Single-Center, Randomized, Partially Blinded Clinical Trial of Fospropofol Versus Midazolam for Moderate Sedation in Patients Undergoing Oral Surgery of 30-45 Minute Duration

Riley, Cara Joy, DMD, MS

Abstract Details

2011, Master of Science, Ohio State University, Dentistry.

Introduction. A regimen of moderate intravenous (IV) sedation combined with local anesthesia is common for outpatient oral surgery procedures. A preferred sedative agent must be safe and well accepted by both patients and practitioners. According to these parameters, this study evaluated fospropofol, a relatively new sedative/hypnotic, in comparison to midazolam, a widely used benzodiazepine, for IV moderate sedation during dental treatment.

Methods. Twenty patients were randomly assigned to either the fospropofol or the midazolam group. Each participant received 1 mcg/kg of fentanyl prior to the sedative agent being administered. Those in the fospropofol group received 6.5 mg/kg initial doses, with 1.6 mg/kg supplemental doses. Those in the midazolam group received 0.05 mg/kg initial doses, followed by 0.02 mg/kg supplemental doses. The quality of sedation in each patient was evaluated with regards to (1) sedation achievement, maintenance, and recovery; (2) patient and surgeon satisfaction; and (3) hemodynamic stability and adverse effects.

Results. The fospropofol group demonstrated significantly higher levels of patient and surgeon satisfaction for the sedation than the midazolam group, with mean 100 mm Visual Analog Scale (VAS) scores of 93.6 versus 75.9 (p=0.005), and 95.2 versus 73.5 (p=0.046) respectively. Fospropofol patients also had significantly shorter recovery times than midazolam patients, taking a mean of 7.10 versus 16.3 minutes for physical recovery (p=0.019), and 6.20 versus 8.20 minutes for cognitive recovery (p=0.007). The fospropofol group also required fewer supplemental doses per minute than the midazolam group, with means of 0.092 versus 0.178 (p=0.002). Two adverse effects demonstrated significance, with more patients in the midazolam group experiencing tachycardia (70% versus 0%, p=0.003), and more patients in the fospropofol group experiencing a short-lived paresthesia (50% versus 0%, p=0.005). No significant difference was found in any other measures of sedation safety, maintenance, or likability.

Conclusion. Fospropofol is a promising new agent that can be considered a safe and reliable alternative to midazolam for IV moderate sedation in the dental setting.

Dr. Simon Prior (Advisor)
Dr. Kelly Kennedy (Committee Member)
Dr. William Johnston (Committee Member)
47 p.

Recommended Citations

Citations

  • Riley, DMD, MS, C. J. (2011). A Single-Center, Randomized, Partially Blinded Clinical Trial of Fospropofol Versus Midazolam for Moderate Sedation in Patients Undergoing Oral Surgery of 30-45 Minute Duration [Master's thesis, Ohio State University]. OhioLINK Electronic Theses and Dissertations Center. http://rave.ohiolink.edu/etdc/view?acc_num=osu1320163603

    APA Style (7th edition)

  • Riley, DMD, MS, Cara. A Single-Center, Randomized, Partially Blinded Clinical Trial of Fospropofol Versus Midazolam for Moderate Sedation in Patients Undergoing Oral Surgery of 30-45 Minute Duration. 2011. Ohio State University, Master's thesis. OhioLINK Electronic Theses and Dissertations Center, http://rave.ohiolink.edu/etdc/view?acc_num=osu1320163603.

    MLA Style (8th edition)

  • Riley, DMD, MS, Cara. "A Single-Center, Randomized, Partially Blinded Clinical Trial of Fospropofol Versus Midazolam for Moderate Sedation in Patients Undergoing Oral Surgery of 30-45 Minute Duration." Master's thesis, Ohio State University, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=osu1320163603

    Chicago Manual of Style (17th edition)