NCT05328973

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Cancer Pain

Interventions

Type	Name	Description
OTHER	ELEQUIL	patch placed on skin

Timeline

• Start date: 2022-05-18
• Primary completion: 2024-01-16
• Completion: 2024-01-16
• First posted: 2022-04-14
• Last updated: 2024-12-02
• Results posted: 2024-12-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study