A Phase 4 interventional study of Self-Administered Nitrous Oxide and Oxygen in Prostate Disease, Malignancy and Benign Prostatic Hyperplasia, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-30.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Supportive care
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.
84 studies on the registry are indexed under Prostatic Diseases; 19 are open to participants now.
This study's enrollment of 143 is above the median of 77 across 66 interventional studies indexed under Prostatic Diseases.
Browse Prostatic Diseases studies →Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
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Exclusion Criteria:
Has any of the following medical conditions:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients will receive 100% oxygen at 10 Liters/minute for the duration of prostate biopsy.
Other: Oxygen
Nitrous oxide administered at concentrations of mild sedation (20-45%) for the duration of prostate biopsy.
Also known as: nitrous oxide
Oxygen will be administered at 10 Liters/min for the duration of prostate biopsy.
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 \[worst pain\])
Time frame: 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 \[worst anxiety\])
Time frame: 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).
Time frame: 5-minutes after prostate biopsy
Time of Prostate Biopsy
Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy
Time frame: Length of prostate biopsy; up to 30 minutes
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).
Time frame: 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).
Time frame: 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).
Time frame: Immediately after prostate biopsy; within 5 minutes after completion of biopsy.
| Milestone | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Started | 66 | 67 |
| Completed | 61 | 67 |
| Not completed | 5 | 0 |
Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Post-biopsy Pain (VAS-P) | 1 (0 to 2) | 1 (0 to 2) |
Anxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Post-biopsy Anxiety (VAS-A) | 0 (0 to 3) | 1 (0 to 3) |
Anxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety).
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Post-biopsy Anxiety Traits (STAI) | 11 (7 to 14) | 12 (9 to 14) |
Length of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy
| minutes | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Time of Prostate Biopsy | 10.6 (9 to 12.6) | 10.3 (8.5 to 11.9) |
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).
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Operator Assessment of "Tolerating Insertion of Rectal Probe" | 2 (2 to 3) | 2 (2 to 3) |
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).
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Operator Assessment of "Patient Maintenance of Positioning" | 2 (2 to 3) | 2 (2 to 3) |
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).
| score on a scale | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Operator Assessment of "Patient Tolerance of Procedure" | 2 (2 to 3) | 2 (2 to 3) |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Self-Administered Nitrous Oxide | 0/61 (0%) | 0/61 (0%) | 1/61 (1.6%) |
| Oxygen | 0/67 (0%) | 0/67 (0%) | 2/67 (3%) |
| Event | Self-Administered Nitrous Oxide | Oxygen |
|---|---|---|
| Facial FlushingGeneral disorders | 1/61 | 0/67 |
| Urinary RetentionRenal and urinary disorders | 0/61 | 1/67 |
| Acute CholangitisHepatobiliary disorders | 0/61 | 1/67 |
| Age, Continuous(years) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Mean | 64.5 ± 11.5 | 65.8 ± 7.8 | 65.2 ± 9.7 |
| Sex: Female, Male(Participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 61 | 67 | 128 |
| Race/Ethnicity, Customized(participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| White | 50 | 56 | 106 |
| Black/African American | 8 | 9 | 17 |
| Other | 3 | 2 | 5 |
| Region of Enrollment(Participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| United States | 61 | 67 | 128 |
| History of Prostate Cancer Prior to Enrollment(Participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Count of participants | 26 | 17 | 43 |
| Past Medical History of Depression(Participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Count of participants | 7 | 10 | 17 |
| Past Medical History of Anxiety(Participants) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Count of participants | 10 | 10 | 20 |
| Pre-Biopsy VAS-Anxiety(units on a scale) | Self-Administered Nitrous Oxide | Oxygen | Total |
|---|---|---|---|
| Median | 3 (0 to 5) | 2 (0 to 5) | 2 (0 to 5) |
2 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD is not intended to be shared to personnel outside of pre-defined research staff.
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Studies of the drug tested here: Nitrous Oxide
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