Perioperative Pharmacogenomic Testing

Anesthesia Clinical Trial

— PPGx  

Official title:

Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063838
• Other study ID #: PeterMac ID 20/85
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2021
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: Michelle D Gerstman, MBBS, MD
• Phone: +61 3 8559 7681
• Email: michelle.gerstman[@]petermac.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single centre, prospective feasibility study and pilot randomised controlled trial of patients scheduled for elective intermediate or major non-cardiac surgery. The investigators plan to randomise up to 200 patients who meet the inclusion criteria to standard care or to personalised perioperative care based on pharmacogenomic testing for drugs commonly used in anaesthesia and postoperative pain management e.g., opioids - morphine, oxycodone and tramadol; anti-emetics - metoclopramide and ondansetron; and non-steroidal drugs - celecoxib and ibuprofen.

The investigators hypothesise that pharmacogenomic testing is feasible prior to elective surgery and through 'personalised prescribing' for precision tailored perioperative care the investigators will improve patient's postoperative quality of recovery, including pain management.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Able to provide written informed consent

2. Age greater than 18 years

3. Elective surgery scheduled greater than 1 week from preoperative assessment and date of pharmacogenomic testing

4. Moderate-Major surgery expecting to last two or more hours with anticipated admission of at least 1 night including: breast, melanoma, colorectal (laparoscopic or open), prostate, or other major surgery (e.g. oesophagectomy, head and neck cancer, retroperitoneal sarcoma, etc.)

Exclusion Criteria:

1. Day case surgery

2. Expected surgery duration of < 2 hours

3. Urgent surgery expected within 1 week of pre-operative assessment

4. Emergency surgery

Related Conditions & MeSH terms

• Anesthesia
• Pharmacogenetics

Intervention

Other:
• Pharmacogenomic optimisation of anaesthetic medications
Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia	University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery.	Percentage of eligible patients approached who consent to participate in the study (yes/no).	Pre-consent
Primary	Pilot RCT - post-operative pain control on day 1 after surgery	Pain on post-operative day 1 as measured by the Numerical Rating Scale (NRS)	Day 1
Secondary	Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).	Percentage of patient test results available on day of surgery	Time of surgery
Secondary	Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.	Patient questionnaire regarding patient perceptions of pharmacogenomic testing	Prior to surgery
Secondary	Actionable genetic variations in our surgical population	Frequency of actionable variations as measured by pharmacogenomic testing	Intraoperative
Secondary	Frequency of change of drug prescribing based on pharmacogenomic testing	Number of changes during the intraoperative period and post-operative period (pharmacogenomic group).	72 hours
Secondary	Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)	Percentage of anesthetists who select "I found the pharmacogenomic results helpful in prescribing".	72 hours
Secondary	Post-operative pain and nausea and vomiting	Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups	30 days
Secondary	Quality of recovery during the postoperative period	Percentage recovery over time of all domains of the PostopQRS™.	30 days
Secondary	Quality of recovery on day 1 postoperatively	QoR-15	Day 1
Secondary	Post-operative pain as measured by total opioid dose	Total opioid dose used within the peri-operative period intra-operative, 0-24, 24-48 & 48-72 hours after surgery.	72 hours
Secondary	Quality of life at post-operative day 30	EQ-5D-5L on POD-30 and Days alive at home within 30 days after surgery (DAH-30).	30 days