Trial Outcomes & Findings for Intraoperative Aromatherapy Versus Placebo for Port-a-Cath Placement Under Monitored Anesthesia Care. A Randomized Controlled Trial (NCT NCT05328973)

NCT ID: NCT05328973

Last Updated: 2024-12-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: from "PACU arrival" to "PACU discharge ready", 1.5 hrs in average
• Results posted on: 2024-12-02

Participant Flow

This study enrolled 70 patients between May 2022 and March 2023. Eligible subjects were identified from within the patient population of the study site by members of the research team.

Participant milestones

Measure	Elequis Aromatab (Lavander/Pepermint) Elequis Aromatab was placed next to patient's pillow	Placebo Placebo tab was placed next to patient's pillow
Overall Study STARTED	35	35
Overall Study COMPLETED	35	34
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Elequis Aromatab (Lavander/Pepermint) Elequis Aromatab was placed next to patient's pillow	Placebo Placebo tab was placed next to patient's pillow
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=35 Participants Placebo tab was placed next to patient's pillow	Total n=70 Participants Total of all reporting groups
Charlson Score >=5	11 Participants n=35 Participants	15 Participants n=35 Participants	26 Participants n=70 Participants
Age, Continuous	52.4 Years STANDARD_DEVIATION 13.225 • n=35 Participants	52.886 Years STANDARD_DEVIATION 15.212 • n=35 Participants	52.64 Years STANDARD_DEVIATION 14.15 • n=70 Participants
Sex: Female, Male Female	28 Participants n=35 Participants	26 Participants n=35 Participants	54 Participants n=70 Participants
Sex: Female, Male Male	7 Participants n=35 Participants	9 Participants n=35 Participants	16 Participants n=70 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI <=25	13 Participants n=35 Participants	13 Participants n=35 Participants	26 Participants n=70 Participants
BMI >25	22 Participants n=35 Participants	22 Participants n=35 Participants	44 Participants n=70 Participants
ASA 2	3 Participants n=35 Participants	0 Participants n=35 Participants	3 Participants n=70 Participants
ASA 3	32 Participants n=35 Participants	35 Participants n=35 Participants	67 Participants n=70 Participants
Charlson Score 0	1 Participants n=35 Participants	3 Participants n=35 Participants	4 Participants n=70 Participants
Charlson Score 1 to 2	8 Participants n=35 Participants	11 Participants n=35 Participants	19 Participants n=70 Participants
Charlson Score 3 to 4	15 Participants n=35 Participants	6 Participants n=35 Participants	21 Participants n=70 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
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 Minutes Standard Deviation 15.376	89.382 Minutes Standard Deviation 21.25

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Anxiety Score (HADS) in Preoperative Holding Area Abnormal	1 Participants	2 Participants
Anxiety Score (HADS) in Preoperative Holding Area Borderline	3 Participants	3 Participants
Anxiety Score (HADS) in Preoperative Holding Area Normal	31 Participants	29 Participants

SECONDARY outcome

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

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

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Midazolam Use Intraoperatively (mg)	3.63 mg Standard Deviation 1.28	3.6 mg Standard Deviation 1.5

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Opioid Use Intraoperatively (in MEDD)	2.59 MEDD Standard Deviation 1.05	2.91 MEDD Standard Deviation 1.5

SECONDARY outcome

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

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

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Intraoperative Anti-emetic Use	4 mg Standard Deviation 0.97	3.41 mg Standard Deviation 1.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Number of Participants With Postoperative Nausea or Vomiting (PONV) in PACU	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Rate and Intensity of PONV in PACU	0 score on a scale Standard Deviation 0	0.0118 score on a scale Standard Deviation 0.0686

SECONDARY outcome

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

Number of Patients given antiemetic medication in PACU

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=24 Participants Placebo tab was placed next to patient's pillow
Anti-emetic Use in PACU	0 Participants	1 Participants

SECONDARY outcome

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

Number of Patients given opioids in PACU

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Opioid Use in PACU	2 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Pain Intensity in PACU (0-10 Numerical Rating Scale)	0.3257 score on a scale Standard Deviation 1.0371	0.5429 score on a scale Standard Deviation 1.0661

SECONDARY outcome

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

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

Outcome measures

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 Participants Elequis Aromatab was placed next to patient's pillow	Placebo n=34 Participants Placebo tab was placed next to patient's pillow
Patient Satisfaction in PACU Unknown	0 Participants	0 Participants
Patient Satisfaction in PACU Somewhat satisfied	0 Participants	2 Participants
Patient Satisfaction in PACU Very much satisfied	35 Participants	32 Participants

Adverse Events

Elequis Aromatab (Lavander/Pepermint)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Elequis Aromatab (Lavander/Pepermint) n=35 participants at risk Elequis Aromatab was placed next to patient's pillow	Placebo n=34 participants at risk Placebo tab was placed next to patient's pillow
Cardiac disorders Arrhythmia	0.00% 0/35 • From "Anesthesia Start" to "PACU Discharge", approximately 3 hours. Number of patients who reported Adverse Events or were observed by health providers	2.9% 1/34 • Number of events 1 • From "Anesthesia Start" to "PACU Discharge", approximately 3 hours. Number of patients who reported Adverse Events or were observed by health providers
Respiratory, thoracic and mediastinal disorders Transient Hypoxemia	2.9% 1/35 • Number of events 1 • From "Anesthesia Start" to "PACU Discharge", approximately 3 hours. Number of patients who reported Adverse Events or were observed by health providers	5.9% 2/34 • Number of events 2 • From "Anesthesia Start" to "PACU Discharge", approximately 3 hours. Number of patients who reported Adverse Events or were observed by health providers

Additional Information

Neil Bailard, MD

M.D. Anderson Cancer Center

Phone: 713-597-1687

Email: nbailard@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place