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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Oxygen | Placebo Comparator | Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Self-Administered Nitrous Oxide | Drug | Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Operator Assessment of "Tolerating Insertion of Rectal Probe" |
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Inclusion Criteria:
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:
Participants with a prostate may be eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Rayala, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21944136 | Background | 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. | |
| 22232535 | 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. |
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IPD is not intended to be shared to personnel outside of pre-defined research staff.
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Of note, 143 patients were consented for procedure, but only 133 were randomized. This discrepancy was due to study staff availability or patient cancellation of procedure.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2022 |
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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).
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The operating urologist and study participant will be blinded to group assignment for the duration of the study.
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| Oxygen | Other | Oxygen will be administered at 10 Liters/min for the duration of 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).
| Immediately after prostate biopsy; within 5 minutes after completion of biopsy. |
| 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. |
| 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. |
| 1819967 | Background | Jastak JT, Donaldson D. Nitrous oxide. Anesth Prog. 1991 Jul-Oct;38(4-5):142-53. No abstract available. |
| 29334501 | 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. |
| FG001 | Oxygen | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy. |
| BG001 | Oxygen | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| History of Prostate Cancer Prior to Enrollment | Count of Participants | Participants |
| ||||||||||||||||
| Past Medical History of Depression | Count of Participants | Participants |
| ||||||||||||||||
| Past Medical History of Anxiety | Count of Participants | Participants |
| ||||||||||||||||
| Pre-Biopsy VAS-Anxiety | Pre-procedural anxiety was assessed using the Visual Analog Scale for Anxiety (VAS-A, range:0-10, higher scores indicating worse anxiety). | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Pre-Biopsy VAS-Pain | Pre-procedural pain was measured by the Visual Analog Scale for Pain (VAS-P, range:0-10, with greater scores indicating worse pain). | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| Pre-Biopsy STAI | Pre-procedural anxiety was assessed using the State Trait Anxiety Inventory (STAI, range:6-24, higher scores indicate worse anxiety) | Median | Inter-Quartile Range | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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]) | Posted | Median | Inter-Quartile Range | score on a scale | 5-minutes after prostate biopsy |
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| 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]) | Posted | Median | Inter-Quartile Range | score on a scale | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Posted | Mean | Inter-Quartile Range | minutes | 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). | Posted | Median | Inter-Quartile Range | score on a scale | 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). | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after prostate biopsy; within 5 minutes after completion of biopsy. |
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| 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). | Posted | Median | Inter-Quartile Range | score on a scale | Immediately after prostate biopsy; within 5 minutes after completion of biopsy. |
|
30 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Self-Administered Nitrous Oxide: Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy. | 0 | 61 | 0 | 61 | 1 | 61 |
| EG001 | Oxygen | 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. | 0 | 67 | 0 | 67 | 2 | 67 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Facial Flushing | General disorders | Systematic Assessment | Facial Flushing during procedure |
| |
| Urinary Retention | Renal and urinary disorders | Systematic Assessment | Urinary Retention with need for catheter |
| |
| Acute Cholangitis | Hepatobiliary disorders | Systematic Assessment | Acute Cholangitis |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Heidi Rayala | Beth Israel Medical Center | 16176673739 | hrayala@bidmc.harvard.edu |
| Nov 28, 2023 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 8, 2022 | Feb 3, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D009369 | Neoplasms |
| D011470 | Prostatic Hyperplasia |
| D011471 | Prostatic Neoplasms |
| D001008 | Anxiety Disorders |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009609 | Nitrous Oxide |
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D009589 | Nitrogen Oxides |
| D005740 | Gases |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D018011 | Chalcogens |
| D004602 | Elements |
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| Black/African American |
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| Other |
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