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Inhaled Anesthetic

Nitrous Oxide for Procedural Pain (SANO-VAS Trial)

Phase 4
Recruiting
Led By Heidi Rayala, MD, PhD
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured during and two weeks after vasectomy
Awards & highlights

SANO-VAS Trial Summary

This trial is looking into whether nitrous oxide can reduce pain and anxiety during vasectomy, and if giving patients control over their own dosage will improve the experience.

Eligible Conditions
  • Procedural Pain
  • Pain Catastrophizing
  • Procedural Anxiety

SANO-VAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured during and two weeks after vasectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured during and two weeks after vasectomy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Procedural pain assessed by the Visual Analog Scale for Pain (VAS-P)
Secondary outcome measures
Anticipated anxiety assessed by the Visual Analog Scale for Anxiety (VAS-A)
Anticipated pain assessed by the Visual Analog Scale for Pain (VAS-P)
Emergent adverse events as assessed by frequency of incidents
+5 more

Side effects data

From 2011 Phase 4 trial • 20 Patients • NCT00967694
19%
Dysphoria
4%
Nausea/vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nitrous Oxide Administration

SANO-VAS Trial Design

1Treatment groups
Experimental Treatment
Group I: Self-adjusted nitrous oxide (SANO)Experimental Treatment1 Intervention
All patients will receive nitrous oxide at concentrations of minimal sedation (0-50%) throughout vasectomy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nitrous oxide
2007
Completed Phase 4
~990

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,195 Total Patients Enrolled
Heidi Rayala, MD, PhDPrincipal InvestigatorBeth Israel Deaconess Medical Center
2 Previous Clinical Trials
162 Total Patients Enrolled
Marissa Kent, MDStudy ChairBeth Israel Deaconess Medical Center

Media Library

Nitrous oxide (Inhaled Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05895383 — Phase 4
Pain Catastrophizing Research Study Groups: Self-adjusted nitrous oxide (SANO)
Pain Catastrophizing Clinical Trial 2023: Nitrous oxide Highlights & Side Effects. Trial Name: NCT05895383 — Phase 4
Nitrous oxide (Inhaled Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05895383 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol for this clinical trial include those aged 45 and older?

"The cut-off for this medical trial is 21 years old as the lowest age and 85 years old as the maximum."

Answered by AI

What potential hazards exist when using Self-adjusted nitrous oxide (SANO) therapeutically?

"The safety of SANO has been verified through a Phase 4 trial, so it is given the top score of 3."

Answered by AI

Are there any enrollment opportunities for this research initiative?

"According to clinicaltrials.gov, this experiment is continuing the process of patient recruitment which began on May 24th 2023 and was recently updated on May 31st of the same year."

Answered by AI

For what demographic is this trial recruiting participants?

"Those looking to join the trial must be between 21 and 85 years old, as well as having a history of pain catastrophizing. The current recruitment goal is 35 participants."

Answered by AI

How many participants are being enrolled in this medical study?

"Affirmative, the data on clinicaltrials.gov demonstrates that this trial is currently accepting participants. The experiment was made public on May 24th 2021 and has since been updated lastly on May 31st 2021. 35 individuals are required from one medical centre for enrollment in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy
Heidi Rayala 2023. "Self-Adjusted Nitrous Oxide: A Feasibility Study in the Setting of Vasectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05895383.
~18 spots leftby Apr 2025
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