Perioperative Pharmacogenomic Testing

Not Applicable

Recruiting

• Conditions: Pharmacogenetics; Anesthesia

• Registration Number: NCT05063838
• Lead Sponsor: Peter MacCallum Cancer Centre, Australia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-01
• Study Start: 2021-11-29
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-19
• Last Update Posted: 2023-05-23
• Primary Completion: 2023-11
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.	Prior to surgery	Patient questionnaire regarding patient perceptions of pharmacogenomic testing
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
Quality of recovery during the postoperative period	30 days	Percentage recovery over time of all domains of the PostopQRS™.
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).

Trial Locations

Locations (1)

Peter MacCallum Cancer Centre; 🇦🇺 Melbourne, Victoria, Australia