Behaviors and Mental Disorders

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Anxiety Disorders

Prostatic Neoplasms

Adenocarcinoma

Pain

Prostatic Hyperplasia

Hyperplasia

Prostatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Male Urogenital Diseases

Mental Disorders

Psychotic Disorders

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Bupivacaine

Nitrous Oxide

Anesthetics

Anesthetics, Inhalation

Anesthetics, General

Analgesics, Non-Narcotic

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.

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

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

Self-Administered Nitrous Oxide

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

Oxygen

Heidi Rayala, MD, PhD

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.

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).

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

Participants with a prostate may be eligible for the study.

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

IPD is not intended to be shared to personnel outside of pre-defined research staff.

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

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

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

Length of procedure will be compared between arms to assess whether SANO significantly lengthens 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).

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).

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).

Brigham and Women's Hospital

Beth Israel Deaconess Medical Center

Principal Investigator

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.

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

Age, Continuous

Sex: Female, Male

White

Black/African American

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

History of Prostate Cancer Prior to Enrollment

Past Medical History of Depression

Past Medical History of Anxiety

Pre-procedural anxiety was assessed using the Visual Analog Scale for Anxiety (VAS-A, range:0-10, higher scores indicating worse anxiety).

Pre-Biopsy VAS-Anxiety

Pre-procedural pain was measured by the Visual Analog Scale for Pain (VAS-P, range:0-10, with greater scores indicating worse pain).

Pre-Biopsy VAS-Pain

Pre-procedural anxiety was assessed using the State Trait Anxiety Inventory (STAI, range:6-24, higher scores indicate worse anxiety)

Pre-Biopsy STAI

Dr. Heidi Rayala

Post-biopsy Pain (VAS-P)

Post-biopsy Anxiety (VAS-A)

Post-biopsy Anxiety Traits (STAI)

Time of Prostate Biopsy

Operator Assessment of "Tolerating Insertion of Rectal Probe"

Operator Assessment of "Patient Maintenance of Positioning"

Operator Assessment of "Patient Tolerance of Procedure"

Overall Study

Digestive System Diseases

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Adjuvants, Anesthesia

Herbal and Botanical

Fentanyl

Ropivacaine

Propofol

Isoflurane

Hypnotics and Sedatives

Anesthetics, Intravenous

Anesthetics, Local

Analgesics, Opioid

Narcotics

Cola

Patients receiving general anesthesia with Fentanyl,Propofol, Isoflurane and Nitrous Oxide only during colonic cancer surgery

Patients receiving general anesthesia and epidural analgesia with Ropivacaine during colonic cancer surgery

Leonid Reytman, MD

Regional anesthesia may decrease the release of endogenous opioids, increase Natural Killer cell (NK) function and decrease development of metastasis. The recent analysis of the Cancer Registry has noted an improved 5-year survival in patients who received epidural analgesia during surgery for colorectal carcinoma.

Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery

All clinical and laboratory parameters from blood samples taken before and after the operation will be compared between the two groups of patients. The nominal data comparison will be performed by ANOVA test, and the nonparametric data will be performed by Mann-Whitney test and interquartile ranges (IQR) for non-normally distributed data.

Hillel Yaffe Medical Center

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Headache

Epilepsy

Congenital Abnormalities

Abdominal Neoplasms

Hydrocephalus

Seizures

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Neurologic Manifestations

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Brain Diseases

Central Nervous System Diseases

Neurofibromatosis

Neurofibromatosis Type 1

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Platelet Aggregation Inhibitors

Dexmedetomidine

Lidocaine

Sevoflurane

Glycopyrrolate

Sodium Channel Blockers

Diuretics, Potassium Sparing

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Muscarinic Antagonists

Cholinergic Antagonists

Cholinergic Agents

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

propofol

single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg

4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group

1 mg/kg intravenous administration prior to propofol administration

Lidocaine 1% Injectable Solution

Inhalation of nitrous oxide may be used for IV placement

Inhalation of sevoflurane may be used for IV placement

Susan P Taylor, MD, MPH

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan.

The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

Recent studies and the FDA have raised concerns that anesthesia for longer than three hours may have effects on behavior and learning. Although investigators do not know if these effects are caused by drugs or the medical condition a child is being treated for, in December 2016, the FDA published the information below regarding anesthesia for children:

General anesthetic and sedation drugs are used to put people into a deep sleep so they do not feel pain during surgery or procedures.

These drugs are usually injected into a vein or breathed in through a mask. General anesthetic and sedation drugs are widely used to ensure the health, safety, and comfort of children and adults undergoing surgery or other procedures.

Recent studies in children suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. More research is still needed to fully understand how anesthetics might affect brain development, especially longer or repeated exposures and in more vulnerable children. Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm Research in neonatal and infant animals has demonstrated that sedative and anesthetic agents, like propofol, produce adverse effects on brain development, including loss of brain cells resulting in long-term, possibly permanent changes in learning and behavior. These adverse effects appear to occur mostly after prolonged periods of sedation or anesthesia (generally greater than 3 hours) and when brain development is occurring at a rapid rate (which roughly occurs in children under 3 years of age). It is not known if similar adverse effects occur in humans. Study participants should be advised that the drugs used to accomplish the procedure may have the potential to increase the loss of nerve cells in the developing brain of young child and that the clinical significance of any such changes is not known. There are some animal studies that suggests dexmedetomidine may be better for a growing infant's brain. However, the effects of dexmedetomidine alone or in combination with propofol on the developing brain have not been thoroughly tested to date." The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. Investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, investigators will administer whatever is necessary. At the end of the study, an observer will record the time it takes for spontaneous eye opening, to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that investigators learn in the following day or two how the participant behaved at home; whether eating, behavior and sleeping were unusual. For that reason, the investigator will call the participant a day or so following the MRI scan.

The investigators expect to recruit 70 children between the ages of 12 and 72 months for the study and hope to have the study completed in 2018.

observer blinded comparison of propofol with low-dose propofol and dexmedetomidine for pediatric MRI sedation

The patients and their parents/guardians as well as the blinded observer or investigator who participates in outcomes assessment will be blinded to the drug or drugs administered.

Dexmedetomidine and Propofol for Pediatric MRI Sedation

An Observer-blinded Randomized Study of Propofol Infusion vs Bolus Dexmedetomidine and Propofol Sedation for Pediatric Magnetic Resonance Imaging

Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

minutes from completion of scan to spontaneous eye opening

minutes from completion of scan to oral/enteral intake

minutes from completion of scan to discharge ready

parental observation of deviation from child's normal habit obtained through follow-up phone call

behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call

Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely

Medical College of Wisconsin

Associate Professor, Department of Pediatric Anesthesiology

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg

Propofol Dexmedetomidine

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mic/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mic/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mic/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Susan Taylor MD

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists.

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg.

Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists

Total Propofol Administered

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center
Influence of Epidural Analgesia on Natural Killer Cell (NK) Activity After Colonic Cancer Surgery	NCT02326727	Colonic Neoplas...	Ropivacaine Fentanyl Propofol Isoflurane Nitrous Oxide	18 Years -	Hillel Yaffe Medical Center
Dexmedetomidine and Propofol for Pediatric MRI Sedation	NCT03513757	Headache Tumor Seizure Disorde... Neurofibromatos... Hydrocephalus Abdominal Neopl... Spine Deformity	propofol Dexmedetomidine Glycopyrrolate Lidocaine 1% In... Nitrous Oxide Sevoflurane	12 Months - 60 Months	Medical College of Wisconsin
Dexmedetomidine and Propofol for Pediatric MRI Sedation	NCT03513757	Headache Tumor Seizure Disorde... Neurofibromatos... Hydrocephalus Abdominal Neopl... Spine Deformity	propofol Dexmedetomidine Glycopyrrolate Lidocaine 1% In... Nitrous Oxide Sevoflurane	12 Months - 60 Months	Medical College of Wisconsin
Self-Administered Nitrous Oxide (SANO) During Transrectal Prostate Biopsy to Reduce Patient Anxiety and Pain	NCT05803096	Prostate Diseas... Malignancy Benign Prostati... Prostate Cancer Prostate Adenoc... Anxiety and Fea... Pain	Self-Administer... Oxygen	18 Years - 85 Years	Beth Israel Deaconess Medical Center

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