Mixture Nitrous Oxide - Oxygen 50-50% in Transrectal Prostate Biopsy Guided by Ultrasound

NCT02899182 | Completed Phase 1

• 1 other identifier: CAZARIMG
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Transrectal ultrasound-guided prostate biopsy (TUPB) is the gold standard diagnostic tool for prostate cancer and, though may be well tolerated for some patients, about 65 to 90% of then still complain of discomfort, weather associated or not to pain. Therefore, as a manner of improvement in visual analogic pain score (VAS) and satisfaction between those patients, the aim of this study is to propose the gas mixture N2O-O2 50-50%, as a non-invasive, safe and cost-effective method to deliver analgesia and/or sedation, without the need for an anesthesiologist. Materials and methods: A randomized clinical trial, simple blind, which took place in Hospital Universitário Antônio Pedro, Niteroi, RJ, within two groups containing 42 patients each, divided in conventional (C), which received 100% oxygen and nitrous oxide (NO), which received inhalation of the mixture N2O-O2 50-50% from a self-demand valve during exam. They were accessed for pain with VAS, answered a satisfaction task and were recorded about collateral side effects.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy

  Reduction on pain intensity evaluated by EVA scale

  12 months

Study Arms (2)

conventional group

PLACEBO COMPARATOR

the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask.

Other: O2

Nitrous Oxide NO

EXPERIMENTAL

The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve

Drug: Nitrous Oxide NO

Interventions

Nitrous Oxide NO DRUG

The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve

Also known as: N2O

Nitrous Oxide NO

O2 OTHER

the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask.

Also known as: conventional

conventional group

Eligibility Criteria

• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing transrectal prostate biopsy guided by ultrasound

You may not qualify if:

• Patients with failure to report the severity of the pain or unable to inhale through the device .
• Patients diagnosed with pulmonary hypertension , severe lung disease, or cardiac failure NYHA 3 and 4.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Fluminense Federal University

Niterói, Rio de Janeiro, 24030-210, Brazil

Location

MeSH Terms

Interventions

Nitrous Oxide; Congresses as Topic

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Organizations; Health Care Economics and Organizations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 14, 2016
• Study Start: April 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: May 9, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)