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Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

NCT02733705 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-09-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Control

normal saline IV

DRUG

Fentanyl

fentanyl 0.5 mcg/kg ideal BW

DRUG

propofol

propofol infusion

Sponsors & Collaborators

  • Mahidol University

    lead OTHER

Principal Investigators

  • Sirilak Suksompong · Mahidol University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Thailand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02733705 on ClinicalTrials.gov