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Completed

NCT Number: NCT05328973

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ELEQUIL

Other

patch placed on skin

Other names: Aromatabs

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

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

    It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready

Secondary outcomes

  1. Anxiety Score (HADS) in Preoperative Holding Area

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

    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

  2. Midazolam Use Intraoperatively (mg)

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

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

  3. Opioid Use Intraoperatively (in MEDD)

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

    The use on intravenous opioids as per Anesthesia record, converted to MEDD (morphine milligram equivalent daily dose)

  4. Intraoperative Anti-emetic Use

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

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

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

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    Measured in assessments done at 1, 15, 30 minutes from PACU start. Patients were asked for nausea or vomiting.

  6. Rate and Intensity of PONV in PACU

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    Measured using the Verbal Numeric Rating Scale (0: no nausea and 10 worst nausea ever), patients were asked how would they rate their PONV.

  7. Anti-emetic Use in PACU

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    Number of Patients given antiemetic medication in PACU

  8. Opioid Use in PACU

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    Number of Patients given opioids in PACU

  9. Pain Intensity in PACU (0-10 Numerical Rating Scale)

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    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.

  10. Patient Satisfaction in PACU

    Time frame: From "PACU Start" to "PACU Discharge", 1.5 hr in average

    Rating the experience in PACU by the patients using the Likert Scale

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2022
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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