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

M.D. Anderson Cancer Center70 enrolled

Overview

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.

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cancer Pain

Interventions

ELEQUILOTHER

patch placed on skin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MD Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

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

Time frame: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average

Secondary Outcomes

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

Time frame: 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.

Time frame: 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)

Time frame: From "Anesthesia Start" to "Anesthesia End". 1hr in average

Intraoperative Anti-emetic Use

The use on intravenous Ondansetron in mg as per Anesthesia record.

Time frame: 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.

Data from ClinicalTrials.gov

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