Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy
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|ClinicalTrials.gov Identifier: NCT02733705|
Recruitment Status : Unknown
Verified January 2018 by Sirilak Suksompong, Mahidol University.
Recruitment status was: Recruiting
First Posted : April 11, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pain||Other: Control Drug: Fentanyl Drug: propofol||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Placebo Comparator: Control
normal saline IV plus propofol infusion
normal saline IV
Active Comparator: Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
fentanyl 0.5 mcg/kg ideal BW
- Pain assess using Numeric rating scale (NRS) score [ Time Frame: 20 minutes ]
- Number of participants with hypoxia defined as oxygen saturation <92% [ Time Frame: 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 [ Time Frame: 60 minutes ]The investigators define hypotension as systolic blood pressure< 90 mmHg. The investigators will report as number of episode.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733705
|Contact: Sirilak Suksompong, MDfirstname.lastname@example.org|
|Bangkok, Thailand, 10700|
|Contact: Sirilak Suksompong, MD 66891534806 email@example.com|
|Principal Investigator:||Sirilak Suksompong||Mahidol University|