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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02733705

Enrollment

124

Registered

2016-04-11

Start date

2017-01-01

Completion date

2018-05-31

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, TRUS biopsy

Brief 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.

Interventions

OTHERControl

normal saline IV

DRUGFentanyl

fentanyl 0.5 mcg/kg ideal BW

DRUGpropofol

propofol infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pain assess using Numeric rating scale (NRS) score	20 minutes

Secondary

Measure	Time frame	Description
Number of participants with hypoxia defined as oxygen saturation <92%	60 minutes	The investigators define hypoxia as oxygen saturation \< 92%. The investigators will report as number of episode.
Number of participants with hypotension, defined as systolic blood pressure <90 mmHg	60 minutes	The investigators define hypotension as systolic blood pressure\< 90 mmHg. The investigators will report as number of episode.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026