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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
Sponsor:
Information provided by (Responsible Party):
Sirilak Suksompong, Mahidol University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Other: Control Drug: Fentanyl Drug: propofol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control
normal saline IV plus propofol infusion
 Other: Control
normal saline IV

Drug: propofol
propofol infusion
Active Comparator: Fentanyl
0.5 mcg/kg ideal body weight IV plus propofol infusion
 Drug: Fentanyl
fentanyl 0.5 mcg/kg ideal BW

Drug: propofol
propofol infusion


Outcome Measures
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Primary Outcome Measures :
  1. Pain assess using Numeric rating scale (NRS) score [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Sirilak Suksompong, MD 66891534806 ssuksompong5@gmail.com

Locations
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Thailand
Sirilak Suksompong Recruiting
Bangkok, Thailand, 10700
Contact: Sirilak Suksompong, MD    66891534806    sirilak.suk@mahidol.ac.th   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sirilak Suksompong Mahidol University
More Information
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Responsible Party: Sirilak Suksompong, Associate Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT02733705    
Other Study ID Numbers: TRUS
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sirilak Suksompong, Mahidol University:
Pain
TRUS biopsy
Additional relevant MeSH terms:
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Fentanyl
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
 Anesthetics
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia