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

Phase 2

Completed

• Conditions: Cancer Pain
• Interventions: Other: ELEQUIL

• Registration Number: NCT05328973
• Lead Sponsor: M.D. Anderson Cancer Center

Brief 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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Study Start: 2022-05-18
• Primary Completion: 2024-01-16
• Study Completion: 2024-01-16
• Results First Submitted: 2024-08-30
• Status Verified: 2024-11
• Results First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Results First Posted: 2024-12-02
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Adult patients (≥ 18 years old)
• Port-a-Cath placement under Monitored Anesthesia Care
• Signed informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ELEQUIL	ELEQUIL	Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
Patient Satisfaction in PACU	From "PACU Start" to "PACU Discharge", 1.5 hr in average	Rating the experience in PACU by the patients using the Likert Scale
Anxiety Score (HADS) in Preoperative Holding Area	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
Midazolam Use Intraoperatively (mg)	From "Anesthesia Start" to "Anesthesia End". 1hr in average	The use on intravenous Midazolam in mg as per Anesthesia record.
Opioid Use Intraoperatively (in MEDD)	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)
Intraoperative Anti-emetic Use	From "Anesthesia Start" to "Anesthesia End". 1hr in average	The use on intravenous Ondansetron in mg as per Anesthesia record.
Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU	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.
Rate and Intensity of PONV in PACU	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.
Anti-emetic Use in PACU	From "PACU Start" to "PACU Discharge", 1.5 hr in average	Number of Patients given antiemetic medication in PACU
Opioid Use in PACU	From "PACU Start" to "PACU Discharge", 1.5 hr in average	Number of Patients given opioids in PACU
Pain Intensity in PACU (0-10 Numerical Rating Scale)	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.

Trial Locations

Locations (1)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States