NCT05803096

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 143 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed description

Nitrous oxide is a well-tolerated inhaled anesthetic that has been used for decades in pediatric and adult populations and is largely viewed as effective and safe. In addition to analgesic effect, nitrous oxide also produces a dissociative euphoria and amnesia that could potentially improve patients' anxiety and experience of cancer care. When used as a single agent at concentrations ≤50%, the American Society of Anesthesiologists (ASA) classifies nitrous oxide as Minimal Sedation, producing a state in which a patient responds normally to verbal commands, maintains airway reflexes, and spontaneous ventilation. Over the past several decades nitrous oxide has become less common due to concerns of nitrous oxide environmental exposure to the care team. There are now Federal Drug Administration (FDA)-approved systems that allow patient self-administered nitrous oxide (SANO), and importantly, include a scavenger system to eliminate exhaled environmental nitrous oxide. These systems are rapidly being adopted throughout the United States in Urology practices, but to date, there have been no studies evaluating patient outcomes and possible risks with the adjunct use of SANO. This study is a prospective, randomized, controlled trial to assess patient perceived pain and anxiety related to prostate needle biopsy with or without SANO, and the frequency of complications associated with SANO. A secondary aim will be to demonstrate that the SANO at the time of prostate biopsy does not significantly increase burden on Urologist productivity, nor increase the difficulty of operator ease in performing the prostate needle biopsy.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-12
• Primary completion: 2022-09-02
• Completion: 2022-09-09
• First posted: 2023-04-07
• Last updated: 2024-01-30
• Results posted: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study