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<p><b>New page</b></p><div><span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">'''Hyperbaric oxygen exposure did not alter the pharmacokinetics of gentamicin in volunteers.''' </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Bottom Line:''' </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. No evidence of altered pharmacokinetics in healthy male volunteers with good creatinine clearance. </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Appraised by:''' Mike Bennett, Dept of Diving and Hyperbaric Medicine, Prince of Wales Hospital </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Sydney; Thursday, 18 March 1999 </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Clinical Scenario:''' Healthy volunteers </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Three-part Question:''' Does hyperbaric oxygen alter the pharmacokinetics of gentamicin? </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Search Terms:''' Gentamicin, pharmacokinetics </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Study:''' </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Non-blinded randomised controlled trial with intention-to-treat. </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">Healthy male volunteers. </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Control group''' (N =5;5 analysed): Gentamicin 1.5 mg/kg IVI over 30 minutes while breathing air at 1ATA. Blood samples taken at 0, 15, 30, 45, 60, 75, 90, 120, 180, 240 and 300 minutes for assay. </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Experimental group''' (N =5;5 analysed): As above , but subjects were in a monoplace hyperbaric chamber breathing 100% oxygen at 2.4ATA. Infusion started 10 minutes into a 90-minute oxygen breathing cycle. </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''The Evidence:''' </span><br />
{| <br />
| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''<span style'''"color: black;">Non-Event Outcomes</span>'''</span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">'''<span style'''"color: black;">Time to outcome</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">'''<span style'''"color: black;">Air group</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">'''<span style'''"color: black;">HBO group</span>'''</span></span> || <span style'''"display: block; text-align: center;"><span style'''"display: block; font-family: Arial,Helvetica,sans-serif; font-size: 110%; text-align: center;">'''<span style'''"color: black;">P-value</span>'''</span></span> <br />
|-<br />
| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''<span style'''"color: black;">Beta half-life (mins)</span>'''</span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">mins</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">115</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">112</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">>0.78</span></span> <br />
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| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''<span style'''"color: black;">Vd (l/kg)</span>'''</span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">end treatment </span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.184</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.201</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">>0.26</span></span> <br />
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| <span style'''"font-family: Arial,Helvetica,sans-serif; font-size: 110%;">'''<span style'''"color: black;">Clearance (l/kg/hr)</span>'''</span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">end treatment</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.0676</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">0.0754</span></span> || <span style'''"display: block; text-align: center;"><span style'''"color: black; display: block; font-family: arial,helvetica,sans-serif; font-size: 110%; text-align: center;">>0.13</span></span> <br />
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|}<br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Comments:''' </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Randomised crossover design, but subjects, (?observers) not blinded. </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">2. Single HBO exposure only does not rule out effects from a prolonged course. </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">3. No information about patients with health problems. </span><br />
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<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''Expiry date:''' January 2022</span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">'''References:''' </span><br />
<span style="font-family: Arial,Helvetica,sans-serif; font-size: 120%;">1. Merritt GJ, Slade JB. Influence of hyperbaric oxygen on the pharmacokinetics of single-dose gentamicin in healthy volunteers. ''Pharmacotherapy'' 1993;13(4):382-5.</span><br />
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