Trial Outcomes & Findings for Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain (NCT NCT05803096)
NCT ID: NCT05803096
Last Updated: 2024-01-30
Results Overview
Pain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
143 participants
Primary outcome timeframe
5-minutes after prostate biopsy
Results posted on
2024-01-30
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
67
|
|
Overall Study
COMPLETED
|
61
|
67
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain
Baseline characteristics by cohort
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
Total
n=128 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 11.5 • n=99 Participants
|
65.8 years
STANDARD_DEVIATION 7.8 • n=107 Participants
|
65.2 years
STANDARD_DEVIATION 9.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
50 participants
n=99 Participants
|
56 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
17 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
2 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=99 Participants
|
67 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
|
History of Prostate Cancer Prior to Enrollment
|
26 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Past Medical History of Depression
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Past Medical History of Anxiety
|
10 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Pre-Biopsy VAS-Anxiety
|
3 units on a scale
n=99 Participants
|
2 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
Pre-Biopsy VAS-Pain
|
0 units on a scale
n=99 Participants
|
0 units on a scale
n=107 Participants
|
0 units on a scale
n=206 Participants
|
|
Pre-Biopsy STAI
|
12 units on a scale
n=99 Participants
|
12 units on a scale
n=107 Participants
|
12 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 5-minutes after prostate biopsyPain experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Pain (VAS-P) (range: 0 \[no pain\] - 10 \[worst pain\])
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Post-biopsy Pain (VAS-P)
|
1 score on a scale
Interval 0.0 to 2.0
|
1 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: 5-minutes after prostate biopsyAnxiety experienced immediately following prostate biopsy as measured by a Visual Analog Scale for Anxiety (VAS-A) (range: 0 \[no anxiety\] - 10 \[worst anxiety\])
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Post-biopsy Anxiety (VAS-A)
|
0 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
PRIMARY outcome
Timeframe: 5-minutes after prostate biopsyAnxious traits exhibited after prostate biopsy as measured by the State Trait Anxiety Inventory (STAI) (range: 6-36; 36 being 'worst' anxiety).
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Post-biopsy Anxiety Traits (STAI)
|
11 score on a scale
Interval 7.0 to 14.0
|
12 score on a scale
Interval 9.0 to 14.0
|
SECONDARY outcome
Timeframe: Length of prostate biopsy; up to 30 minutesLength of procedure will be compared between arms to assess whether SANO significantly lengthens prostate biopsy
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Time of Prostate Biopsy
|
10.6 minutes
Interval 9.0 to 12.6
|
10.3 minutes
Interval 8.5 to 11.9
|
SECONDARY outcome
Timeframe: Immediately after prostate biopsy; within 5 minutes after completion of 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).
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Operator Assessment of "Tolerating Insertion of Rectal Probe"
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Immediately after prostate biopsy; within 5 minutes after completion of biopsy.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).
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Operator Assessment of "Patient Maintenance of Positioning"
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Immediately after prostate biopsy; within 5 minutes after completion of biopsy.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).
Outcome measures
| Measure |
Self-Administered Nitrous Oxide
n=61 Participants
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.
|
Oxygen
n=67 Participants
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.
|
|---|---|---|
|
Operator Assessment of "Patient Tolerance of Procedure"
|
2 score on a scale
Interval 2.0 to 3.0
|
2 score on a scale
Interval 2.0 to 3.0
|
Adverse Events
Self-Administered Nitrous Oxide
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Oxygen
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Self-Administered Nitrous Oxide
n=61 participants at risk
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.
|
Oxygen
n=67 participants at risk
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.
|
|---|---|---|
|
General disorders
Facial Flushing
|
1.6%
1/61 • Number of events 1 • 30 days
|
0.00%
0/67 • 30 days
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/61 • 30 days
|
1.5%
1/67 • Number of events 1 • 30 days
|
|
Hepatobiliary disorders
Acute Cholangitis
|
0.00%
0/61 • 30 days
|
1.5%
1/67 • Number of events 1 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place