Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

normal saline IV plus propofol infusion

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

normal saline IV

propofol

Intervention Type DRUG

propofol infusion

Fentanyl

0.5 mcg/kg ideal body weight IV plus propofol infusion

Group Type ACTIVE_COMPARATOR

Fentanyl

Intervention Type DRUG

fentanyl 0.5 mcg/kg ideal BW

propofol

Intervention Type DRUG

propofol infusion

Interventions

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Control

normal saline IV

Intervention Type OTHER

Fentanyl

fentanyl 0.5 mcg/kg ideal BW

Intervention Type DRUG

propofol

propofol infusion

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No