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
Overview
- Phase
- Phase 4
- Intervention
- Control
- Conditions
- Pain
- Sponsor
- Mahidol University
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Pain assess using Numeric rating scale (NRS) score
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Sirilak Suksompong
Associate Professor
Mahidol University
Eligibility Criteria
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
Arms & Interventions
Control
normal saline IV plus propofol infusion
Intervention: Control
Control
normal saline IV plus propofol infusion
Intervention: propofol
Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
Intervention: Fentanyl
Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
Intervention: propofol
Outcomes
Primary Outcomes
Pain assess using Numeric rating scale (NRS) score
Time Frame: 20 minutes
Secondary Outcomes
- Number of participants with hypoxia defined as oxygen saturation <92%(60 minutes)
- Number of participants with hypotension, defined as systolic blood pressure <90 mmHg(60 minutes)