Perioperative Pharmacogenomic Testing

NCT05063838 | Unknown

• 1 other identifier: PeterMac ID 20/85
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacogenetics; Anesthesia

Keywords

Drug metabolism; Pharmacogenomics; Individualised care; Postoperative pain; Quality of recovery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).

  Time of surgery

• Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.

  Prior to surgery

• Actionable genetic variations in our surgical population

  Intraoperative

• Frequency of change of drug prescribing based on pharmacogenomic testing

  72 hours

• Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)

  72 hours

Study Arms (2)

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.

Other: Pharmacogenomic optimisation of anaesthetic medications

Control group

NO INTERVENTION

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

Interventions

Pharmacogenomic optimisation of anaesthetic medications OTHER

Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.

Pharmacogenomic group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent
• Age greater than 18 years
• Elective surgery scheduled greater than 1 week from preoperative assessment and date of pharmacogenomic testing
• 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.)

You may not qualify if:

• Day case surgery
• Expected surgery duration of \< 2 hours
• Urgent surgery expected within 1 week of pre-operative assessment
• Emergency surgery

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead
• University of Adelaide: collaborator

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Michelle D Gerstman, MBBS, MD

CONTACT

+61 3 8559 7681; michelle.gerstman@petermac.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: October 1, 2021
• Study Start: November 29, 2021
• Primary Completion: November 1, 2023
• Study Completion: July 1, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05

Locations

AU (1)