CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 143 enrolled
Drug / intervention
Self-Administered Nitrous Oxide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05803096
NCT05803096Phase 4Completed
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Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

Beth Israel Deaconess Medical Center·interventional·Posted Apr 7, 2023·Updated Jan 30, 2024

In Brief

A Phase 4 clinical trial evaluating Self-Administered Nitrous Oxide and Oxygen for Prostate Disease and 6 related conditions. Completed, enrolled 143 participants across 1 site.

Detailed Summary

Transrectal prostate biopsy is a commonly performed ambulatory procedure for diagnosing prostate cancer. Prostate biopsy are associated with pain or anxiety. Nitrous oxide (or laughing gas) is a well-known inhaled anesthetic which is frequently used in dental offices and for pediatric procedures to alleviate a patient's anxiety and pain. This study seeks to determine whether administration of nitrous oxide at the time of prostate biopsy will improve a patient's experience of care.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Disease, Malignancy, Benign Prostatic Hyperplasia, Prostate Cancer, Prostate Adenocarcinoma, Anxiety and Fear, Pain
CountriesUnited States
CollaboratorsBrigham and Women's Hospital

Timeline

Phase 4CompletedFinished
20222023202420252026
First PostedApr 7, 2023
Enrollment StartDec 12, 2021
Primary CompletionSep 2, 2022
Study CompletionSep 9, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.2 years ago

Interventions

Self-Administered Nitrous Oxidedrug

Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.

Oxygenother

Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.