Clinical trial NCT05063838: Perioperative Pharmacogenomic Testing
Official title: Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pharmacogenetics
Anesthesia
Keywords: Drug metabolism
Pharmacogenomics
Individualised care
Postoperative pain
Quality of recovery
Lead sponsor: Peter MacCallum Cancer Centre, Australia
Sponsor class: OTHER
Collaborators: name: University of Adelaide
First posted: 2021-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery.
timeFrame: Pre-consent
measure: Pilot RCT - post-operative pain control on day 1 after surgery
timeFrame: Day 1
Secondary outcomes:
measure: Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).
timeFrame: Time of surgery
measure: Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
timeFrame: Prior to surgery
measure: Actionable genetic variations in our surgical population
timeFrame: Intraoperative
measure: Frequency of change of drug prescribing based on pharmacogenomic testing
timeFrame: 72 hours
measure: Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)
timeFrame: 72 hours
measure: Post-operative pain and nausea and vomiting
timeFrame: 30 days
measure: Quality of recovery during the postoperative period
timeFrame: 30 days
measure: Quality of recovery on day 1 postoperatively
timeFrame: Day 1
measure: Post-operative pain as measured by total opioid dose
timeFrame: 72 hours
measure: Quality of life at post-operative day 30
timeFrame: 30 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Peter MacCallum Cancer Centre
state: Victoria
Study officials:
References: