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

NCT05328973 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2021-0994NCI-2022-03112
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Pain

Outcome Measures

Primary Outcomes (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

  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

Secondary Outcomes (10)

• Anxiety Score (HADS) in Preoperative Holding Area

  From "In preop" to "Preop end" per EMR. 1hr in average

• Midazolam Use Intraoperatively (mg)

  From "Anesthesia Start" to "Anesthesia End". 1hr in average

• Opioid Use Intraoperatively (in MEDD)

  From "Anesthesia Start" to "Anesthesia End". 1hr in average

• Intraoperative Anti-emetic Use

  From "Anesthesia Start" to "Anesthesia End". 1hr in average

• Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU

  From "PACU Start" to "PACU Discharge", 1.5 hr in average

Study Arms (1)

ELEQUIL

OTHER

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

Other: ELEQUIL

Interventions

ELEQUIL OTHER

patch placed on skin

Also known as: Aromatabs

ELEQUIL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥ 18 years old)
• Port-a-Cath placement under Monitored Anesthesia Care
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 38502819 DERIVED

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Cancer Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Neil Bailard, MD
• Organization: M.D. Anderson Cancer Center

nbailard@mdanderson.org

713-597-1687

Study Officials

• Neil Bailard, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 14, 2022
• Study Start: May 18, 2022
• Primary Completion: January 16, 2024
• Study Completion: January 16, 2024
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Locations

US (1)