Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Pain

Treatments: Drug: Fentanyl; Drug: propofol; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02733705

TRUS

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

124 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

normal saline IV plus propofol infusion

Treatment:

Drug: propofol

Other: Control

Fentanyl

Active Comparator group

Description:

0.5 mcg/kg ideal body weight IV plus propofol infusion

Treatment:

Drug: propofol

Drug: Fentanyl