Perioperative Pharmacogenomic Testing (PPGx)

Peter MacCallum Cancer Centre, Australia

Status: Enrolling

Conditions: Pharmacogenetics; Anesthesia

Treatments: Other: Pharmacogenomic optimisation of anaesthetic medications

Study type: Interventional

Funder types: Other

Identifiers

NCT05063838

PeterMac ID 20/85

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Pharmacogenomic group

Experimental group

Description:

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.

Treatment:

Other: Pharmacogenomic optimisation of anaesthetic medications

Control group

No Intervention group

Description:

Perioperative care will be managed according to current 'standard care' practice at Peter MacCallum Cancer Centre.