Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Sponsor

Mahidol University (Other)

Overall Status

Completed

CT.gov ID

NCT02733705

Collaborator

(none)

124

Enrollment

Location

Arms

16.9

Actual Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Other: Control Drug: Fentanyl Drug: propofol	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

May 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control normal saline IV plus propofol infusion	Other: Control normal saline IV Drug: propofol propofol infusion
Active Comparator: Fentanyl 0.5 mcg/kg ideal body weight IV plus propofol infusion	Drug: Fentanyl fentanyl 0.5 mcg/kg ideal BW Drug: propofol propofol infusion

Arm

Intervention/Treatment

Placebo Comparator: Control

normal saline IV plus propofol infusion

Other: Control

normal saline IV

Drug: propofol

propofol infusion

Active Comparator: Fentanyl

0.5 mcg/kg ideal body weight IV plus propofol infusion

Drug: Fentanyl

fentanyl 0.5 mcg/kg ideal BW

Drug: propofol

propofol infusion

Outcome Measures

Primary Outcome Measures

Pain assess using Numeric rating scale (NRS) score [20 minutes]

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sirilak Suksompong	Bangkok		Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator: Sirilak Suksompong, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sirilak Suksompong, Associate Professor, Mahidol University

ClinicalTrials.gov Identifier:

NCT02733705

Other Study ID Numbers:

TRUS

First Posted:

Apr 11, 2016

Last Update Posted:

Sep 1, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Sirilak Suksompong, Associate Professor, Mahidol University

Pain

TRUS biopsy

Additional relevant MeSH terms:

Fentanyl

Propofol

Study Results

No Results Posted as of Sep 1, 2021