Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Phase 4

Completed

• Conditions: Pain
• Interventions: Other: Control; Drug: Fentanyl; Drug: propofol

• Registration Number: NCT02733705
• Lead Sponsor: Mahidol University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-27
• Study First Submitted QC: 2016-04-08
• Study First Posted: 2016-04-11
• Study Start: 2017-01-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	normal saline IV plus propofol infusion
Control	propofol	normal saline IV plus propofol infusion
Fentanyl	propofol	0.5 mcg/kg ideal body weight IV plus propofol infusion
Fentanyl	Fentanyl	0.5 mcg/kg ideal body weight IV plus propofol infusion

Primary Outcome Measures

Name	Time	Method
Pain assess using Numeric rating scale (NRS) score	20 minutes

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Sirilak Suksompong; 🇹🇭 Bangkok, Thailand