PharmacogeneticsPPGxNCT05063838
Perioperative Pharmacogenomic Testing
A study testing Pharmacogenomic optimisation of anaesthetic medications in people with Pharmacogenetics and Anesthesia, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pharmacogenetics, Anesthesia
- What is being tested?
- Pharmacogenomic optimisation of anaesthetic medications
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Nov 2021to Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- Day case surgery
- Expected surgery duration of < 2 hours
- Urgent surgery expected within 1 week of pre-operative assessment
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Michelle Gerstman, michelle.gerstman@petermac.org
Bernhard Riedel, bernhard.riedel@petermac.org
About this study
Official title: Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study
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
- Being tested
- Pharmacogenomic optimisation of anaesthetic medications
- Keywords
- Drug metabolism, Pharmacogenomics, Individualised care, Postoperative pain, Quality of recovery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacogenomic optimisation of anaesthetic medicationsOther
Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: Day 1
Secondary outcomes (10)
Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).
Percentage of patient test results available on day of surgery
Measured: Time of surgery
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
Patient questionnaire regarding patient perceptions of pharmacogenomic testing
Measured: Prior to surgery
Actionable genetic variations in our surgical population
Frequency of actionable variations as measured by pharmacogenomic testing
Measured: Intraoperative
Frequency of change of drug prescribing based on pharmacogenomic testing
Number of changes during the intraoperative period and post-operative period (pharmacogenomic group).
Measured: 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".
Measured: 72 hours
Post-operative pain and nausea and vomiting
Percentage recovery of the nociceptive domain of the PostopQRS™ scale between groups
Measured: 30 days
Quality of recovery during the postoperative period
Percentage recovery over time of all domains of the PostopQRS™.
Measured: 30 days
Quality of recovery on day 1 postoperatively
QoR-15
Measured: 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.
Measured: 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).
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start29 Nov 2021
- Primary completionNov 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacogeneticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Adelaide
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063838
- Sponsor's protocol ID
- PeterMac ID 20/85
- Acronym
- PPGx
- Status last verified
- May 2023
- First submitted
- 6 Sep 2021
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Pharmacogenomic Testing (PPGx) : A Feasibility and Randomised Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05063838
- Acronym / sponsor ID
- PPGx / PeterMac ID 20/85
- Conditions
- Pharmacogenetics, Anesthesia
- Keywords
- Drug metabolism, Pharmacogenomics, Individualised care, Postoperative pain, Quality of recovery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Collaborators
- University of Adelaide
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacogenomic group | Experimental | Other: Pharmacogenomic optimisation of anaesthetic medicationsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.)
Key exclusion criteria (4 listed)
- Day case surgery
- Expected surgery duration of < 2 hours
- Urgent surgery expected within 1 week of pre-operative assessment
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacogenomic optimisation of anaesthetic medicationsPersonalisation of anaesthetic plan based on pharmacogenomic results and international guidelines. | Other | Pharmacogenomic group |
Primary outcome
Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery.
Time frame: 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
Time frame: Day 1
Pain on post-operative day 1 as measured by the Numerical Rating Scale (NRS)
10 secondary outcomes
Patient pharmacognemic test result availability prior to surgery (i.e. timely test result availability).
Time frame: Time of surgery
Patient perceptions of pharmacogenomic testing and reasons patients decline to participate.
Time frame: Prior to surgery
Actionable genetic variations in our surgical population
Time frame: Intraoperative
Frequency of change of drug prescribing based on pharmacogenomic testing
Time frame: 72 hours
Anesthesia team perceived benefit of modifying perioperative drug choice based on pharmacogenomic results (pharmacogenomic group)
Time frame: 72 hours
Post-operative pain and nausea and vomiting
Time frame: 30 days
Quality of recovery during the postoperative period
Time frame: 30 days
Quality of recovery on day 1 postoperatively
Time frame: Day 1
Post-operative pain as measured by total opioid dose
Time frame: 72 hours
Quality of life at post-operative day 30
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacogenomic optimisation of anaesthetic medications in people with Pharmacogenetics and Anesthesia, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle D Gerstman, MBBS, MD (+61 3 8559 7681, michelle.gerstman@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - patient acceptability of pre-operative pharmacogenomic testing prior to their scheduled intermediate-major surgery. (time frame: Pre-consent). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.