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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-03112 | Other Identifier | NCI-CTRP-Clinical Trial Reporting Registry |
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This is a prospective, controlled, randomized trial. Primary objective is to compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo. 70 Eligible subjects will be identified from within the patient population of the study site. There will be no advertisements for study subjects.
Primary Objective:
To compare the time to readiness for discharge (minutes) from Post-Anesthesia Care Unit (PACU) after Port-a-Cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.
Secondary Objective:
To evaluate the following secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELEQUIL | Other | Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ELEQUIL | Other | patch placed on skin |
|
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| Measure | Description | Time Frame |
|---|---|---|
| To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo | It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready | from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety Score (HADS) in Preoperative Holding Area | The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression. The HADS has 14 items, divided into two subscales of seven items each, and each item is scored on a 4-point Likert scale ranging from 0-3. Scores are interpreted as follows: 0-7: Normal 8-10: Borderline 11-21: Abnormal | From "In preop" to "Preop end" per EMR. 1hr in average |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Bailard, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38502819 | Derived | Bailard N, Cukierman DS, Guerra-Londono JJ, Brown E, Hagberg C, Sauer A, Cata JP. Use of a Combination Lavender/Peppermint Aromatherapy Patch During Port Catheter Placement Under Monitored Anesthesia Care Does Not Reduce Time to Discharge Readiness: A Randomized Controlled Trial. J Integr Complement Med. 2024 Sep;30(9):840-847. doi: 10.1089/jicm.2023.0416. Epub 2024 Mar 19. |
| Label | URL |
|---|---|
| M D Anderson Cancer Center | View source |
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This study enrolled 70 patients between May 2022 and March 2023. Eligible subjects were identified from within the patient population of the study site by members of the research team.
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| ID | Title | Description |
|---|---|---|
| FG000 | Elequis Aromatab (Lavander/Pepermint) | Elequis Aromatab was placed next to patient's pillow |
| FG001 | Placebo | Placebo tab was placed next to patient's pillow |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Elequis Aromatab (Lavander/Pepermint) | Elequis Aromatab was placed next to patient's pillow |
| BG001 | Placebo | Placebo tab was placed next to patient's pillow |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | To Compare the Time to Readiness for Discharge From PACU (Minutes) After Port-a-Cath Placement Surgery Between Patients Who Are Randomized to Receive Intraoperative Aromatherapy Versus Placebo | It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready | Posted | Mean | Standard Deviation | Minutes | from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average |
|
From "Anesthesia Start" to "PACU Discharge", approximately 3 hours.
Number of patients who reported Adverse Events or were observed by health providers
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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 | Elequis Aromatab (Lavander/Pepermint) | Elequis Aromatab was placed next to patient's pillow |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Bailard, MD | M.D. Anderson Cancer Center | 713-597-1687 | nbailard@mdanderson.org |
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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 | Feb 6, 2023 | Aug 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Midazolam Use Intraoperatively (mg) | The use on intravenous Midazolam in mg as per Anesthesia record. | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
| Opioid Use Intraoperatively (in MEDD) | The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose) | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
| Intraoperative Anti-emetic Use | The use on intravenous Ondansetron in mg as per Anesthesia record. | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
| Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU | Measured in assessments done at 1, 15, 30 minutes from PACU start. Patients were asked for nausea or vomiting. | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| Rate and Intensity of PONV in PACU | Measured using the Verbal Numeric Rating Scale (0: no nausea and 10 worst nausea ever), patients were asked how would they rate their PONV. | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| Anti-emetic Use in PACU | Number of Patients given antiemetic medication in PACU | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| Opioid Use in PACU | Number of Patients given opioids in PACU | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| Pain Intensity in PACU (0-10 Numerical Rating Scale) | Pain intensity reported by the patients during their stay in PACU, using the the numerical rating scale (NRS) 0 to 10, whereas 0 means no pain, and 10 means the worst possible pain. | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| Patient Satisfaction in PACU | Rating the experience in PACU by the patients using the Likert Scale | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Subject were staged according to their Body Mass Index in the two categories below. | Count of Participants | Participants |
|
| ASA | American Society of Anesthesiologists Physical Status Classification ranges from 1 to 6, where 1 is for a normal healthy patient, and 6 for a Brain-dead patient whose organs are being harvested. During this study, patients with a classification 2 & 3 qualified and enrolled. | Count of Participants | Participants |
|
| Charlson Score | CCI score ranged from 0 to 11. The scores were categorized into the following groups: 0, 1-2, 3-4, and >=5. A higher score means high comorbid disease increasing anesthesia risk. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Anxiety Score (HADS) in Preoperative Holding Area | The Hospital Anxiety and Depression Scale (HADS) is a self-report questionnaire that measures anxiety and depression. The HADS has 14 items, divided into two subscales of seven items each, and each item is scored on a 4-point Likert scale ranging from 0-3. Scores are interpreted as follows: 0-7: Normal 8-10: Borderline 11-21: Abnormal | Posted | Count of Participants | Participants | From "In preop" to "Preop end" per EMR. 1hr in average |
|
|
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| Secondary | Midazolam Use Intraoperatively (mg) | The use on intravenous Midazolam in mg as per Anesthesia record. | Posted | Mean | Standard Deviation | mg | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
|
|
|
| Secondary | Opioid Use Intraoperatively (in MEDD) | The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose) | Posted | Mean | Standard Deviation | MEDD | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
|
|
|
| Secondary | Intraoperative Anti-emetic Use | The use on intravenous Ondansetron in mg as per Anesthesia record. | Posted | Mean | Standard Deviation | mg | From "Anesthesia Start" to "Anesthesia End". 1hr in average |
|
|
|
| Secondary | Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU | Measured in assessments done at 1, 15, 30 minutes from PACU start. Patients were asked for nausea or vomiting. | Posted | Count of Participants | Participants | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| Secondary | Rate and Intensity of PONV in PACU | Measured using the Verbal Numeric Rating Scale (0: no nausea and 10 worst nausea ever), patients were asked how would they rate their PONV. | Posted | Mean | Standard Deviation | score on a scale | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| Secondary | Anti-emetic Use in PACU | Number of Patients given antiemetic medication in PACU | Posted | Count of Participants | Participants | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| Secondary | Opioid Use in PACU | Number of Patients given opioids in PACU | Posted | Count of Participants | Participants | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| Secondary | Pain Intensity in PACU (0-10 Numerical Rating Scale) | Pain intensity reported by the patients during their stay in PACU, using the the numerical rating scale (NRS) 0 to 10, whereas 0 means no pain, and 10 means the worst possible pain. | Posted | Mean | Standard Deviation | score on a scale | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| Secondary | Patient Satisfaction in PACU | Rating the experience in PACU by the patients using the Likert Scale | Posted | Count of Participants | Participants | From "PACU Start" to "PACU Discharge", 1.5 hr in average |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 1 |
| 35 |
| EG001 | Placebo | Placebo tab was placed next to patient's pillow | 0 | 34 | 0 | 34 | 3 | 34 |
| Transient Hypoxemia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| Normal |
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| Very much satisfied |
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