Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733705
• Other study ID #: TRUS
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: August 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Other:
• Control
normal saline IV

Drug:
• Fentanyl
fentanyl 0.5 mcg/kg ideal BW
• propofol
propofol infusion

Locations

Country	Name	City	State
Thailand	Sirilak Suksompong	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assess using Numeric rating scale (NRS) score		20 minutes
Secondary	Number of participants with hypoxia defined as oxygen saturation <92%	The investigators define hypoxia as oxygen saturation < 92%. The investigators will report as number of episode.	60 minutes
Secondary	Number of participants with hypotension, defined as systolic blood pressure <90 mmHg	The investigators define hypotension as systolic blood pressure< 90 mmHg. The investigators will report as number of episode.	60 minutes