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

• Sponsor: Beth Israel Deaconess Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05803096
• Collaborator: Brigham and Women's Hospital (Other)
• Enrollment: 128
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 14.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Disease; Malignancy; Benign Prostatic Hyperplasia; Prostate Cancer; Prostate Adenocarcinoma; Anxiety and Fear; Pain	Drug: Self-Administered Nitrous Oxide; Other: Oxygen	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).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).
• Masking: Double (Participant, Care Provider)
• Masking Description: The operating urologist and study participant will be blinded to group assignment for the duration of the study.
• Primary Purpose: Supportive Care
• Official Title: Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
• Actual Study Start Date: Dec 12, 2021
• Actual Primary Completion Date: Sep 2, 2022
• Actual Study Completion Date: Sep 9, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Self-Administered Nitrous Oxide 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; Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.; Other Names: nitrous oxide
Placebo Comparator: Oxygen Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.	Other: Oxygen; Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.

Outcome Measures

Primary Outcome Measures

1. Post-biopsy pain (VAS-P) [5-minutes after prostate biopsy]

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

2. Post-biopsy anxiety (VAS-A) [5-minutes after prostate biopsy]

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

3. Post-biopsy anxiety traits (STAI) [5-minutes after prostate biopsy]

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

Secondary Outcome Measures

1. Time of prostate biopsy [Length of prostate biopsy; up to 30 minutes]

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

2. Operator ease of performing procedure [Immediately after prostate biopsy]

   Operating urologist will be asked to fill out a three-item "operator survey" that asks if "Insertion of rectal probe," "patient maintenance of positioning," and "patient tolerance of procedure," was "worse than expected (-1)", "as expected (0)" or "better than expected (+1)" the composite score will be compared between groups

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Heidi Rayala, MD, PhD, Beth Israel Deaconess Medical Center

Study Documents (Full-Text)

• Informed Consent Form - Aug 8, 2022

More Information

Publications

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

• Responsible Party: Heidi Rayala, Principal Investigator, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT05803096
• Other Study ID Numbers: 2021P-000715
• First Posted: Apr 7, 2023
• Last Update Posted: Apr 7, 2023
• Last Verified: Mar 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Heidi Rayala, Principal Investigator, Beth Israel Deaconess Medical Center: prostate biopsy; nitrous oxide; prostate cancer; ambulatory; patient experience of care
• Additional relevant MeSH terms: Prostatic Neoplasms; Prostatic Hyperplasia; Prostatic Diseases; Hyperplasia; Anxiety Disorders; Nitrous Oxide

Study Results

No Results Posted as of Apr 7, 2023