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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
200
Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
RECRUITINGFeasibility - 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).
Time frame: Pre-consent
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)
Time frame: Day 1
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 frame: Time of surgery
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
Patient questionnaire regarding patient perceptions of pharmacogenomic testing
Time frame: Prior to surgery
Actionable genetic variations in our surgical population
Frequency of actionable variations as measured by pharmacogenomic testing
Time frame: Intraoperative
Frequency of change of drug prescribing based on pharmacogenomic testing
Number of changes during the intraoperative period and post-operative period (pharmacogenomic group).
Time frame: 72 hours
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".
Time frame: 72 hours
Post-operative pain and nausea and vomiting
Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups
Time frame: 30 days
Quality of recovery during the postoperative period
Percentage recovery over time of all domains of the PostopQRS™.
Time frame: 30 days
Quality of recovery on day 1 postoperatively
QoR-15
Time frame: Day 1
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.
Time frame: 72 hours
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).
Time frame: 30 days
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