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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05803096
• Other study ID #: 2021P-000715
• Status: Completed
• Phase: Phase 4
• Start date: December 12, 2021
• Est. completion date: September 9, 2022

Study information

• Verified date: January 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: September 9, 2022
• Est. primary completion date: September 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Inner ear, bariatric or eye surgery within the last 2 weeks,

2. Current emphysematous blebs,

3. Severe B-12 deficiency.

4. Bleomycin chemotherapy within the past year.

5. Class III or higher heart failure.

6. Undergoing novel therapy for prostate cancer

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Time of Prostate Biopsy	Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy	Length of prostate biopsy; up to 30 minutes
Secondary	Operator Assessment of "Tolerating Insertion of Rectal Probe"	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).	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.
Secondary	Operator Assessment of "Patient Maintenance of Positioning"	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).	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.
Secondary	Operator Assessment of "Patient Tolerance of Procedure"	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).	Immediately after prostate biopsy; within 5 minutes after completion of biopsy.