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

Cancer Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Cancer Pain

• NCT number: NCT05328973
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2022
• Completion date: January 16, 2024