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| Name | Class |
|---|---|
| University of Adelaide | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacogenomic group | Experimental | The perioperative (anesthetic and postoperative pain management) plan for each patient will be determined preoperatively by the treating anesthesia team. Thereafter, the pharmacogenomic results of the patient will be released and a personalised anesthetic plan formulated based on international pharmacogenomic guidelines. The treating anesthesia team will then modify the perioperative care plan based on the patients' pharmacogenomic results and the international pharmacogenomic guidelines. |
|
| Control group | No Intervention | Perioperative care will be managed according to current 'standard care' practice at Peter MacCallum Cancer Centre. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmacogenomic optimisation of anaesthetic medications | Other | Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Patient perceptions of pharmacogenomic testing and reasons patients decline to participate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michelle D Gerstman, MBBS, MD | Contact | +61 3 8559 7681 | michelle.gerstman@petermac.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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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.
Patient questionnaire regarding patient perceptions of pharmacogenomic testing |
| Prior to surgery |
| Actionable genetic variations in our surgical population | Frequency of actionable variations as measured by pharmacogenomic testing | Intraoperative |
| 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 |
| 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 |
| Post-operative pain and nausea and vomiting | Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups | 30 days |
| Quality of recovery during the postoperative period | Percentage recovery over time of all domains of the PostopQRS™. | 30 days |
| Quality of recovery on day 1 postoperatively | QoR-15 | 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. | 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). | 30 days |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |