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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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