Clinical trial · Interventional
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
NCT05328973CI-TRIAL-00083178completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ELEQUIL | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- ELEQUIL
- description
- Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.
- interventionNames
- Other: ELEQUIL
Primary outcomes (1)
- measure
- 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
- timeFrame
- from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
- description
- It measures the time to readiness for discharge from PACU (minutes) from PACU arrival to PACU discharge ready
Secondary outcomes (10)
- measure
- Anxiety Score (HADS) in Preoperative Holding Area
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBailard 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. PMID 38502819