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Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain

NCT05803096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2024-01-30

Study results available
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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.

Conditions

  • Prostate Disease
  • Malignancy
  • Benign Prostatic Hyperplasia
  • Prostate Cancer
  • Prostate Adenocarcinoma
  • Anxiety and Fear
  • Pain

Interventions

DRUG

Self-Administered Nitrous Oxide

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

OTHER

Oxygen

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

Sponsors & Collaborators

Principal Investigators

  • Heidi Rayala, MD, PhD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-12
Primary Completion
2022-09-02
Completion
2022-09-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT05803096 on ClinicalTrials.gov