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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328973
• Other study ID #: 2021-0994
• Secondary ID: NCI-2022-03112
• Status: Completed
• Phase: Phase 2
• Start date: May 18, 2022
• Est. completion date: January 16, 2024

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 16, 2024
• Est. primary completion date: January 16, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Pain

Intervention

Other:
• ELEQUIL
patch placed on skin

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		through study completion, an average of 1 year
Secondary	Anxiety score (HADS) in preoperative holding area		Up to 2 years
Secondary	Midazolam use intraoperatively (mg)		Up to 2 years
Secondary	Intraoperative opioid use (morphine equivalents)		Up to 2 years
Secondary	Intraoperative anti-emetic use		Up to 2 years
Secondary	Time to first occurrence of postoperative nausea or vomiting (PONV) in PACU		Up to 2 years
Secondary	Rate and intensity of PONV in PACU		Up to 2 years
Secondary	Anti-emetic use in PACU		Up to 2 years
Secondary	Opioid use in PACU (morphine equivalent)		Up to 2 years
Secondary	Pain intensity in PACU	Pain intensity using the Verbal Numeric Rating Scale (0: no pain and 10 worst pain ever) every 15 minutes from procedure end until a Parsap score of 18 or more is reached.	Up to 2 years
Secondary	Patient satisfaction in PACU	Patient satisfaction (Patient-Reported Outcome, Likert scale), assessed as soon as a Parsap score of 18 or more has been reached.	Up to 2 years

External Links

•   M D Anderson Cancer Center