Intravenous Propofol and Fentanyl vs Propofol for Sedation in TRUS Biopsy

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Pain

Intervention / Treatment
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* Other: Control
* Drug: Fentanyl
* Drug: propofol


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>normal saline IV plus propofol infusion | Other: Control<br>* normal saline IV<br>Drug: propofol<br>* propofol infusion<br>|
| Active Comparator: Fentanyl<br>0.5 mcg/kg ideal body weight IV plus propofol infusion | Drug: Fentanyl<br>* fentanyl 0.5 mcg/kg ideal BW<br>Drug: propofol<br>* propofol infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assess using Numeric rating scale (NRS) score |  | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, TRUS biopsy