PainPhase 4NCT02733705
Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy
A Phase 4 study testing Fentanyl and propofol in people with Pain, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Pain
- What is being tested?
- Fentanyl and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2017to 31 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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
- Pain
- Keywords
- Pain, TRUS biopsy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | normal saline IV plus propofol infusion Receives: Other: Control; Drug: propofol |
| Fentanyl | Active comparator | 0.5 mcg/kg ideal body weight IV plus propofol infusion Receives: Drug: Fentanyl; Drug: propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assess using Numeric rating scale (NRS) score
Measured: 20 minutes
Secondary outcomes (2)
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.
Measured: 60 minutes
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.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sirilak Suksompong, Mahidol University
- Investigators
- Sirilak Suksompong, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733705
- Sponsor's protocol ID
- TRUS
- Status last verified
- Aug 2021
- First submitted
- 27 Mar 2016
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Suksompong S, Limratana P, Saengsomsuan N, Wongsawang N, Chaikittisilpa N. Propofol with or without fentanyl for pain relief after transrectal ultrasound-guided prostate (TRUS-P) biopsy: a randomized controlled study. Braz J Anesthesiol. 2021 Jul-Aug;71(4):345-351. doi: 10.1016/j.bjane.2021.02.001. Epub 2021 Feb 3.
PubMed 34229860
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02733705
- Acronym / sponsor ID
- TRUS
- Conditions
- Pain
- Keywords
- Pain, TRUS biopsy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 11 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Control, Drug: propofolnormal saline IV plus propofol infusion |
| Fentanyl | Active comparator | Drug: Fentanyl, Drug: propofol0.5 mcg/kg ideal body weight IV plus propofol infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlnormal saline IV | Other | Control |
| Fentanylfentanyl 0.5 mcg/kg ideal BW | Drug | Fentanyl |
| propofolpropofol infusion | Drug | Control, Fentanyl |
Primary outcome
Pain assess using Numeric rating scale (NRS) score
Time frame: 20 minutes
2 secondary outcomes
Number of participants with hypoxia defined as oxygen saturation <92%
Time frame: 60 minutes
Number of participants with hypotension, defined as systolic blood pressure <90 mmHg
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Derived from this study: PubMed 34229860Suksompong S, Limratana P, Saengsomsuan N, Wongsawang N, Chaikittisilpa N. Propofol with or without fentanyl for pain relief after transrectal ultrasound-guided prostate (TRUS-P) biopsy: a randomized controlled study. Braz J Anesthesiol. 2021 Jul-Aug;71(4):345-351. doi: 10.1016/j.bjane.2021.02.001. Epub 2021 Feb 3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Suksompong principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fentanyl and propofol in people with Pain, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain assess using Numeric rating scale (NRS) score (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02733705, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.