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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 September 2021 |
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Main ID: |
NCT02733705 |
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Date of registration:
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27/03/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy
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Scientific title:
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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 |
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Date of first enrolment:
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January 1, 2017 |
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Target sample size:
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124 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02733705 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 4
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Sirilak Suksompong |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Pain
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Intervention(s)
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Other: Control
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Drug: propofol
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Drug: Fentanyl
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Primary Outcome(s)
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Pain assess using Numeric rating scale (NRS) score
[Time Frame: 20 minutes]
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Secondary Outcome(s)
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Number of participants with hypoxia defined as oxygen saturation <92%
[Time Frame: 60 minutes]
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Number of participants with hypotension, defined as systolic blood pressure <90 mmHg
[Time Frame: 60 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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