Trial intelligence / Profile preview

SANO in Prostate Biopsy

NCT05803096Phase 4

Key facts

Status: Completed
Start: Dec 2021
Primary completion: Sep 2022
Countries: 1
Sponsor: Beth Israel Deaconess Medical Center
Modality: Small Molecules

Drugs: nitrous oxide
Conditions: painanxiety disorder

Overview

Phase 4, randomised, single-blind trial of nitrous oxide in pain and anxiety disorder (2 arms), sponsored by Beth Israel Deaconess Medical Center. Primary endpoints: Post-biopsy Pain, Post-biopsy Anxiety and 1 more. Started Dec 2021; status: completed.

Design

2 arms

Study design: RandomizedSingle-blind

Self-Administered Nitrous Oxide
Nitrous oxide (30-45%) + Oxygen
Oxygen
100% Oxygen

Who it enrols

Adult males scheduled for prostate biopsy, excluding those with facial hair impeding mask seal, recent inner ear/eye/bariatric surgery, severe B12 deficiency, heart failure, or recent bleomycin chemotherapy.

Endpoints

Primary

Post-biopsy Pain5 minutes post-biopsy
Post-biopsy Anxiety5 minutes post-biopsy
Post-biopsy Anxiety Traits5 minutes post-biopsy

Secondary

Time of Prostate Biopsyup to 30 minutes
Operator Assessment of Tolerating Insertion of Rectal Probe5 minutes post-biopsy
Operator Assessment of Patient Maintenance of Positioning5 minutes post-biopsy
Operator Assessment of Patient Tolerance of Procedure5 minutes post-biopsy

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