AnesthesiaPhase 1/2NCT02899182
Mixture Nitrous Oxide - Oxygen 50-50% in Transrectal Prostate Biopsy Guided by Ultrasound
A Phase 1/2 study testing Nitrous Oxide NO and O2 in people with Anesthesia, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- Nitrous Oxide NO and O2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2016to Mar 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing transrectal prostate biopsy guided by ultrasound
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Introduction:
Transrectal ultrasound-guided prostate biopsy (TUGP) is currently the gold standard method used for early cancer diagnosis of this gland, when associated with PSA plasma measurement. Although well tolerated by many patients, about 65-90% of men undergoing BPTU complain of discomfort, associated or not to pain. For better tolerance, various methods of analgesia and / or sedation have been proposed, such as nerve block periprostatic ( or intraprostatic, topical anesthesia with lidocaine or EMLA at the puncture site , general anesthesia with propofol and remifentanil and other invasive techniques.
Inhalation of N2O-O2 50-50% by self-demand valve proposed in this study can be a good alternative to invasive methods to be a safe technique, cost-effective, which promotes analgesia on demand, in order to increase the tolerance painful procedures as TUGP, regardless of the presence of anesthesiologists.
Nitrous oxide (N2O) can be self administered for analgesia in various procedures such as drug joint intra injections, vascular access puncture, flexible sigmoidoscopy and colonoscopy, ophthalmic procedures and prostate biopsy. In Europe it is used in emergencies in the care and transport accidents in ambulances.
The objective is to evaluate the efficiency of inhalation of N2O-O2 50-50% by self-demand valve, comparing it to a placebo group. In addition, investigators evaluated side events such as the adverse effects of administration of nitrous oxide to discuss their security procedures without the presence of anesthesiologist.
Materials and methods:
The trial will be done at Antonio Pedro University Hospital, Niterói, RJ - Brazil. Currently, the procedure is performed in the hospital outpatient clinics, without anesthesia.
Included patients are those undergoing transrectal prostate biopsy guided by ultrasound. Patients with failure to report the severity of the pain or unable to inhale through the device or Patients diagnosed with pulmonary hypertension, severe lung disease, or cardiac failure NYHA 3 and 4 will be excluded from the study The free and informed consent will be presented and signed by each volunteer participant, and the benefits of research clarified. 84 patients undergoing TUGP an outpatient will be randomized into two groups of 42. The conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask (standard technique used routinely in our Hospital for this procedure). The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve An anesthesiologist will monitor the examinations respecting the resolution of the Federal Council of Medicine No. 1.802 / 2006, without being able to intervene in analgesia proposed by randomization. A visual analogy scale (VAS) pain 0-10 and a satisfaction form will be presented to the patient before the procedure and answered after it. The group will receive the mixture of N2O, O2 will be evaluated for the incidence of nausea, vomiting, dizziness, hemodynamic changes, fit of laughter and sleepiness during the examination.
- Conditions
- Anesthesia
- Being tested
- Nitrous Oxide NO, O2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrous Oxide NODrug
Also called N2O
The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve
O2Other
Also called conventional
the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask.
| Study group | Role | What they receive |
|---|---|---|
| conventional group | Placebo comparator | the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask. Receives: 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 Receives: Drug: Nitrous Oxide NO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy
Reduction on pain intensity evaluated by EVA scale
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismar Lima Cavalcanti, Universidade Federal Fluminense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899182
- Sponsor's protocol ID
- CAZARIMG
- Status last verified
- May 2018
- First submitted
- 17 Aug 2016
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixture Nitrous Oxide - Oxygen 50-50% in Transrectal Prostate Biopsy Guided by Ultrasound
- ClinicalTrials.gov ID
- NCT02899182
- Acronym / sponsor ID
- CAZARIMG
- Conditions
- Anesthesia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
Transrectal ultrasound-guided prostate biopsy (TUGP) is currently the gold standard method used for early cancer diagnosis of this gland, when associated with PSA plasma measurement. Although well tolerated by many patients, about 65-90% of men undergoing BPTU complain of discomfort, associated or not to pain. For better tolerance, various methods of analgesia and / or sedation have been proposed, such as nerve block periprostatic ( or intraprostatic, topical anesthesia with lidocaine or EMLA at the puncture site , general anesthesia with propofol and remifentanil and other invasive techniques.
Inhalation of N2O-O2 50-50% by self-demand valve proposed in this study can be a good alternative to invasive methods to be a safe technique, cost-effective, which promotes analgesia on demand, in order to increase the tolerance painful procedures as TUGP, regardless of the presence of anesthesiologists.
Nitrous oxide (N2O) can be self administered for analgesia in various procedures such as drug joint intra injections, vascular access puncture, flexible sigmoidoscopy and colonoscopy, ophthalmic procedures and prostate biopsy. In Europe it is used in emergencies in the care and transport accidents in ambulances.
The objective is to evaluate the efficiency of inhalation of N2O-O2 50-50% by self-demand valve, comparing it to a placebo group. In addition, investigators evaluated side events such as the adverse effects of administration of nitrous oxide to discuss their security procedures without the presence of anesthesiologist.
Materials and methods:
The trial will be done at Antonio Pedro University Hospital, Niterói, RJ - Brazil. Currently, the procedure is performed in the hospital outpatient clinics, without anesthesia.
Included patients are those undergoing transrectal prostate biopsy guided by ultrasound. Patients with failure to report the severity of the pain or unable to inhale through the device or Patients diagnosed with pulmonary hypertension, severe lung disease, or cardiac failure NYHA 3 and 4 will be excluded from the study The free and informed consent will be presented and signed by each volunteer participant, and the benefits of research clarified. 84 patients undergoing TUGP an outpatient will be randomized into two groups of 42. The conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask (standard technique used routinely in our Hospital for this procedure). The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve An anesthesiologist will monitor the examinations respecting the resolution of the Federal Council of Medicine No. 1.802 / 2006, without being able to intervene in analgesia proposed by randomization. A visual analogy scale (VAS) pain 0-10 and a satisfaction form will be presented to the patient before the procedure and answered after it. The group will receive the mixture of N2O, O2 will be evaluated for the incidence of nausea, vomiting, dizziness, hemodynamic changes, fit of laughter and sleepiness during the examination.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional group | Placebo comparator | Other: O2the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask. |
| Nitrous Oxide NO | Experimental | Drug: Nitrous Oxide NOThe NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing transrectal prostate biopsy guided by ultrasound
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nitrous Oxide NOAlso: N2OThe NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve | Drug | Nitrous Oxide NO |
| O2Also: conventionalthe conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask. | Other | conventional group |
Primary outcome
Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy
Time frame: 12 months
Reduction on pain intensity evaluated by EVA scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitrous Oxide NO and O2 in people with Anesthesia, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction in patients undergoing transrectal ultrasound-guided prostate biopsy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2018.