Anesthesia, Pharmacogenetics
Conditions
Keywords
Drug metabolism, Pharmacogenomics, Individualised care, Postoperative pain, Quality of recovery
Brief 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.
Interventions
OTHERPharmacogenomic optimisation of anaesthetic medications
Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.
Sponsors
University of Adelaide
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Patients will remain blinded until the completion of data collection on post-operative day 30. Investigators assessing postoperative outcomes will remain blinded throughout study. Treating clinicians and study investigators will be unblinded to the pharmacogenomic results available for patients randomised to the active arm of the study group. Treating clinicians will remain blinded to the pharmacogenomic results available for patients randomised to the control arm of the study group, as this group will receive standard care that is provided at Peter MacCallum Cancer Centre.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery. | Pre-consent | Percentage of eligible patients approached who consent to participate in the study (yes/no). |
| Pilot RCT - post-operative pain control on day 1 after surgery | Day 1 | Pain on post-operative day 1 as measured by the Numerical Rating Scale (NRS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actionable genetic variations in our surgical population | Intraoperative | Frequency of actionable variations as measured by pharmacogenomic testing |
| Frequency of change of drug prescribing based on pharmacogenomic testing | 72 hours | Number of changes during the intraoperative period and post-operative period (pharmacogenomic group). |
| Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group) | 72 hours | Percentage of anesthetists who select I found the pharmacogenomic results helpful in prescribing. |
| Post-operative pain and nausea and vomiting | 30 days | Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups |
| Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability). | Time of surgery | Percentage of patient test results available on day of surgery |
| Quality of recovery on day 1 postoperatively | Day 1 | QoR-15 |
| Post-operative pain as measured by total opioid dose | 72 hours | Total opioid dose used within the peri-operative period intra-operative, 0-24, 24-48 & 48-72 hours after surgery. |
| Quality of life at post-operative day 30 | 30 days | EQ-5D-5L on POD-30 and Days alive at home within 30 days after surgery (DAH-30). |
| Quality of recovery during the postoperative period | 30 days | Percentage recovery over time of all domains of the PostopQRS™. |
| Patient perceptions of pharmacogenomic testing and reasons patients decline to participate. | Prior to surgery | Patient questionnaire regarding patient perceptions of pharmacogenomic testing |
Countries
Australia
Contacts
Primary ContactMichelle D Gerstman, MBBS, MD
Outcome results
None listed