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

M.D. Anderson Cancer Center

Status and phase: Completed; Phase 2

Conditions: Cancer Pain

Treatments: Other: ELEQUIL

Study type: Interventional

Funder types: Other

Identifiers

NCT05328973

2021-0994

NCI-2022-03112 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

ELEQUIL

Other group

Description:

Aromatherapy will be provided using a lavender-peppermint patch called an Aromatab.

Treatment:

Other: ELEQUIL