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

NCT ID: NCT05328973

Last Updated: 2024-12-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-18

Study Completion Date

2024-01-16

Brief Summary

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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

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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

Conditions

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Cancer Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ELEQUIL

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

Group Type OTHER

ELEQUIL

Intervention Type OTHER

patch placed on skin

Interventions

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ELEQUIL

patch placed on skin

Intervention Type OTHER

Other Intervention Names

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Aromatabs

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neil Bailard, MD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38502819 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

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NCI-2022-03112

Identifier Type: OTHER

Identifier Source: secondary_id

2021-0994

Identifier Type: -

Identifier Source: org_study_id