NCT02733705

Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

A Randomised Controlled Trial Comparing Combined Intravenous Propofol and Fentanyl Versus Intravenous Propofol Alone for Sedation in Patients Undergoing Transrectal Ultrasound-guided (TRUS) Prostate Biopsy

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain

Interventions

Type	Name	Description
OTHER	Control	normal saline IV
DRUG	Fentanyl	fentanyl 0.5 mcg/kg ideal BW
DRUG	propofol	propofol infusion

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2016-04-11
• Last updated: 2021-09-01

Locations

1 site across 1 country: Thailand