Behaviors and Mental Disorders

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Anxiety Disorders

Prostatic Neoplasms

Adenocarcinoma

Pain

Prostatic Hyperplasia

Hyperplasia

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Bupivacaine

Nitrous Oxide

Anesthetics

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

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

Self-Administered Nitrous Oxide

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

Oxygen

Heidi Rayala, MD, PhD

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.

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.

Subjects will be randomized 1:1 to either SANO (treatment) or oxygen (placebo control) after completion of baseline assessment. The results of the randomization will not be disclosed to patients as part of the study (patient-blinded).

The operating urologist and study participant will be blinded to group assignment for the duration of the study.

Participants with a prostate may be eligible for the study.

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

IPD is not intended to be shared to personnel outside of pre-defined research staff.

Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])

Anxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])

Anxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety).

Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy

Operating urologist filled out a survey to assess their perception of patient: Tolerating Insertion of rectal probe. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient maintenance of positioning. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Operating urologist filled out a survey to assess their perception of patient: Patient Tolerance of Procedure. Responses were scored on a 3-point Likert scale as 1 (worse than expected), 2 (as expected), or 3 (better than expected).

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Principal Investigator

Patients will receive SANO in addition to periprostatic bupivacaine nerve block for the duration of prostate biopsy.

After the Urologist describes the procedure, the SANO group will have nitrous oxide turned on to 30%, ensuring that the patient is relaxed but still conversant through the procedure. The nitrous will be adjust up or down based on the patient's response to the question "are you feeling the nitrous" and "are you happy at this level". The range will be between 25 - 45%. At the end of the procedure, the SANO group will be turned down to 0% nitrous oxide, and 100% oxygen will be administered through the mask for an additional 2-3 minutes as the patient is cleaned up and repositioned to the supine position.

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

Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.

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

Total

Age, Continuous

Sex: Female, Male

White

Black/African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

History of Prostate Cancer Prior to Enrollment

Past Medical History of Depression

Past Medical History of Anxiety

Pre-procedural anxiety was assessed using the Visual Analog Scale for Anxiety (VAS-A, range:0-10, higher scores indicating worse anxiety).

Pre-Biopsy VAS-Anxiety

Pre-procedural pain was measured by the Visual Analog Scale for Pain (VAS-P, range:0-10, with greater scores indicating worse pain).

Pre-Biopsy VAS-Pain

Pre-procedural anxiety was assessed using the State Trait Anxiety Inventory (STAI, range:6-24, higher scores indicate worse anxiety)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for patient experience of care