CompletedPhase 4

Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Thailand124 participantsStarted 2017-01-01

Plain-language summary

Nowadays, TRUS biopsy become one of the most popular tests for diagnosis of prostate cancer. This procedure causes pain to the patients who does not received the sedative drugs or analgesic drugs. There are many ways to reduce pain and inconvenience for the patients, such as intravenous propofol, intravenous fentanyl etc. In Siriraj hospital, anesthesiologists usually give intravenous propofol with intravenous opioids but the visual analogue score after this procedure was average at 0.9-2.9. Furthermore, some systematic reviews have shown that there was no difference in pain score between periprostatic nerve block plus opioid and periprostatic nerve block only. So, this study is to find out whether opioids is need for TRUS biopsy.

Who can participate

Age range18 Years

SexMALE

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Inclusion Criteria: * Age over 18 year * Patient American society of anesthesiology physical status I-III. * Scheduled for Transrectal ultrasound-guided prostate biopsy * BMI equal to or less than 30 kg/cm2 Exclusion Criteria: * Known hypersensitivity to propofol or fentanyl * History of bleeding tendency * Known case of active anal or rectal disease * Unable to rate pain score * History of drug abuse * Chronic opioid use

What they're measuring

Pain assess using Numeric rating scale (NRS) score

Timeframe: 20 minutes

Trial details

NCT IDNCT02733705

SponsorMahidol University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-05-31

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