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

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

• Status: Completed
• Conditions: Cancer Pain
• Intervention / Treatment: Other: ELEQUIL

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

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

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 (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 25, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Cancer Pain
• 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