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

NCT05803096 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2021P-000715
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

prostate biopsy; nitrous oxide; prostate cancer; ambulatory; patient experience of care

Outcome Measures

Primary Outcomes (3)

• Post-biopsy Pain (VAS-P)

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

  5-minutes after prostate biopsy

• Post-biopsy Anxiety (VAS-A)

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

  5-minutes after prostate biopsy

• Post-biopsy Anxiety Traits (STAI)

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

  5-minutes after prostate biopsy

Secondary Outcomes (4)

• Time of Prostate Biopsy

  Length of prostate biopsy; up to 30 minutes

• Operator Assessment of "Tolerating Insertion of Rectal Probe"

  Immediately after prostate biopsy; within 5 minutes after completion of biopsy.

• Operator Assessment of "Patient Maintenance of Positioning"

  Immediately after prostate biopsy; within 5 minutes after completion of biopsy.

• Operator Assessment of "Patient Tolerance of Procedure"

  Immediately after prostate biopsy; within 5 minutes after completion of biopsy.

Study Arms (2)

Self-Administered Nitrous Oxide

ACTIVE COMPARATOR

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.

Drug: Self-Administered Nitrous Oxide

Oxygen

PLACEBO COMPARATOR

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

Other: Oxygen

Interventions

Self-Administered Nitrous Oxide DRUG

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

Also known as: nitrous oxide

Self-Administered Nitrous Oxide

Oxygen OTHER

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

Oxygen

Eligibility Criteria

• Age: 18 Years - 85 Years
• Gender Eligibility Details: Participants with a prostate may be eligible for the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biological male
• Aged 18 to 85 years
• Scheduled for clinically-indicated prostate needle biopsy
• Suitable for nitrous oxide/oxygen with willingness to be randomized to inhaled SANO or inhaled oxygen during the procedure
• Access to an email and computer

You may not qualify if:

• Perioral facial hair impeding good mask seal
• Learning disabilities and/or inability to cognitively complete survey questions
• Taken a pre-procedure benzodiazepine or narcotic.
• Has any of the following medical conditions:
• Inner ear, bariatric or eye surgery within the last 2 weeks,
• Current emphysematous blebs,
• Severe B-12 deficiency.
• Bleomycin chemotherapy within the past year.
• Class III or higher heart failure.
• Undergoing novel therapy for prostate cancer

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

• Loeb S, Carter HB, Berndt SI, Ricker W, Schaeffer EM. Complications after prostate biopsy: data from SEER-Medicare. J Urol. 2011 Nov;186(5):1830-4. doi: 10.1016/j.juro.2011.06.057. Epub 2011 Sep 23.

  PMID: 21944136 BACKGROUND

• Rosario DJ, Lane JA, Metcalfe C, Donovan JL, Doble A, Goodwin L, Davis M, Catto JW, Avery K, Neal DE, Hamdy FC. Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study. BMJ. 2012 Jan 9;344:d7894. doi: 10.1136/bmj.d7894.

  PMID: 22232535 BACKGROUND

• Jastak JT, Donaldson D. Nitrous oxide. Anesth Prog. 1991 Jul-Oct;38(4-5):142-53. No abstract available.

  PMID: 1819967 BACKGROUND

• Practice Guidelines for Moderate Procedural Sedation and Analgesia 2018: A Report by the American Society of Anesthesiologists Task Force on Moderate Procedural Sedation and Analgesia, the American Association of Oral and Maxillofacial Surgeons, American College of Radiology, American Dental Association, American Society of Dentist Anesthesiologists, and Society of Interventional Radiology. Anesthesiology. 2018 Mar;128(3):437-479. doi: 10.1097/ALN.0000000000002043. No abstract available.

  PMID: 29334501 BACKGROUND

MeSH Terms

Conditions

Prostatic Diseases; Neoplasms; Prostatic Hyperplasia; Prostatic Neoplasms; Anxiety Disorders; Pain

Interventions

Nitrous Oxide; Oxygen

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Chalcogens; Elements

Results Point of Contact

• Title: Dr. Heidi Rayala
• Organization: Beth Israel Medical Center

hrayala@bidmc.harvard.edu

16176673739

Study Officials

• Heidi Rayala, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The operating urologist and study participant will be blinded to group assignment for the duration of the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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).

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: April 7, 2023
• Study Start: December 12, 2021
• Primary Completion: September 2, 2022
• Study Completion: September 9, 2022
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)