Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Primary Purpose
Cancer Pain
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ELEQUIL
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Pain
Eligibility Criteria
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
Sites / Locations
- MD Anderson Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
ELEQUIL
Arm Description
Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05328973
First Posted
April 5, 2022
Last Updated
May 25, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05328973
Brief Title
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Official Title
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELEQUIL
Arm Type
Other
Arm Description
Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.
Intervention Type
Other
Intervention Name(s)
ELEQUIL
Other Intervention Name(s)
Aromatabs
Intervention Description
patch placed on skin
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Bailard, MD
Phone
(713) 597-1687
Email
nbailard@mdanderson.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Bailard, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Bailard, MD
Phone
713-597-1687
Email
nbailard@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Neil Bailard, MD
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
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