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Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05328973
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
28.5
Anticipated Duration (Months)
2.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ELEQUIL
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Actual Study Start Date :
May 18, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: ELEQUIL

Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.

Other: ELEQUIL
patch placed on skin
Other Names:
  • Aromatabs

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: Neil Bailard, MD, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05328973
    Other Study ID Numbers:
    • 2021-0994
    • NCI-2022-03112
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    May 20, 2022
    Last Verified:
    Apr 1, 2022
    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
    Additional relevant MeSH terms:
    Cancer Pain

    Study Results

    No Results Posted as of May 20, 2022