MedTrace Logo

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

NCT02899182 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2018-05-09

No results posted yet for this study

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

Interventions

DRUG

Nitrous Oxide NO

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

OTHER

O2

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

Sponsors & Collaborators

  • Universidade Federal Fluminense

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02899182 on ClinicalTrials.gov