- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05328973
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
February 12, 2024 updated by: M.D. Anderson Cancer Center
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.
Study Overview
Detailed Description
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:
- Anxiety score (HADS) in preoperative holding area
- Midazolam use intraoperatively (mg)
- Itraoperative opioid use (morphine equivalents)
- Intraoperative anti-emetic use
- Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
- Rate and intensity of PONV in PACU
- Antiemetic use in PACU
- Opioid use in PACU (morphine equivalents)
- Pain intensity in PACU (0-10 numerical rating scale)
- Patient satisfaction in PACU
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- MD Anderson Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult patients (≥ 18 years old)
- Port-a-Cath placement under Monitored Anesthesia Care
- Signed informed consent
Exclusion Criteria:
- Patients undergoing other surgical procedures during Port-a-Cath placement (including explantation of a Port-a-Cath or other previous vascular access device)
- Patients requiring general anesthesia or those not eligible for MAC
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: ELEQUIL
Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.
|
patch placed on skin
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety score (HADS) in preoperative holding area
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Midazolam use intraoperatively (mg)
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Intraoperative opioid use (morphine equivalents)
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Intraoperative anti-emetic use
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Rate and intensity of PONV in PACU
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Anti-emetic use in PACU
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Opioid use in PACU (morphine equivalent)
Time Frame: Up to 2 years
|
Up to 2 years
|
|
Pain intensity in PACU
Time Frame: Up to 2 years
|
Pain intensity using the Verbal Numeric Rating Scale (0: no pain and 10 worst pain ever) every 15 minutes from procedure end until a Parsap score of 18 or more is reached.
|
Up to 2 years
|
Patient satisfaction in PACU
Time Frame: Up to 2 years
|
Patient satisfaction (Patient-Reported Outcome, Likert scale), assessed as soon as a Parsap score of 18 or more has been reached.
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Bailard, MD, M.D. Anderson Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 18, 2022
Primary Completion (Actual)
January 16, 2024
Study Completion (Actual)
January 16, 2024
Study Registration Dates
First Submitted
April 5, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Actual)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0994
- NCI-2022-03112 (Other Identifier: NCI-CTRP-Clinical Trial Reporting Registry)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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