This phase II trial compares aromatherapy to placebo during port-a-cath placement surgery in reducing time to discharge from the post-anesthesia care unit after surgery. A port-a-cath is a device placed under the skin to allow the delivery of treatments and fluids or the drawing of blood. Port-a-cath placement is commonly done under a type of sedation called monitored anesthesia care. Anxiety during surgery (intraoperative anxiety) is a common problem with this kind of anesthesia and may be associated with prolonged recovery after surgery, pain perception, and unnecessary hospitalizations. Aromatherapy, the therapeutic use of essential oils, may offer a simple, low-risk, and cost-effective method of managing intraoperative anxiety. Giving aromatherapy during port-a-cath placement surgery may reduce intraoperative anxiety and reduce time to discharge from post-anesthesia care unit after surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05328973.
PRIMARY OBJECTIVE:
I. To compare the time to readiness for discharge from post-anesthesia care unit (PACU) (minutes) after port-a-cath placement surgery between patients who are randomized to receive intraoperative aromatherapy versus placebo.
SECONDARY OBJECTIVES:
I. Anxiety score (Hospital Anxiety and Depression Score [HADS]) in preoperative holding area.
II. Midazolam use intraoperatively (mg).
III. Intraoperative opioid use (morphine equivalents).
IV. Intraoperative anti-emetic use.
V. Time to first occurrence of postoperative nausea or vomiting in PACU.
VI. Rate and intensity of postoperative nausea and vomiting (PONV) in PACU.
VII. Antiemetic use in PACU.
VIII. Opioid use in PACU (morphine equivalents).
IX. Pain intensity in PACU (0-10 numerical rating scale).
X. Patient satisfaction in PACU.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive aromatherapy during port-a-cath placement surgery.
ARM II: Patients receive placebo during port-a-cath placement surgery.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorNeil S. Bailard
