Phase 2
Completed N=70
Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial
Source: ClinicalTrials.gov NCT05328973 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: 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 — 82.057; 89.382 Minutes
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
82.057; 89.382 | — |
| SECONDARY Anxiety Score (HADS) in Preoperative Holding Area |
1; 2; 3; 3; 31; 29 | — |
| SECONDARY Midazolam Use Intraoperatively (mg) |
3.63; 3.6 | — |
| SECONDARY Opioid Use Intraoperatively (in MEDD) |
2.59; 2.91 | — |
| SECONDARY Intraoperative Anti-emetic Use |
4; 3.41 | — |
| SECONDARY Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU |
0; 1 | — |
| SECONDARY Rate and Intensity of PONV in PACU |
0; 0.0118 | — |
| SECONDARY Anti-emetic Use in PACU |
0; 1 | — |
| SECONDARY Opioid Use in PACU |
2; 3 | — |
| SECONDARY Pain Intensity in PACU (0-10 Numerical Rating Scale) |
0.3257; 0.5429 | — |
| SECONDARY Patient Satisfaction in PACU |
0; 0; 0; 2; 35; 32 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05328973). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.