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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-12

Study Completion Date

2022-09-09

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

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

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Self-Administered Nitrous Oxide

Intervention Type DRUG

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

Oxygen

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

Group Type PLACEBO_COMPARATOR

Oxygen

Intervention Type OTHER

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

Interventions

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Self-Administered Nitrous Oxide

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

Intervention Type DRUG

Oxygen

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

Intervention Type OTHER

Other Intervention Names

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nitrous oxide

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes