Perioperative Pharmacogenomic Testing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2024-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pharmacogenetics Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Pharmacogenomic group

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.

Group Type EXPERIMENTAL

Pharmacogenomic optimisation of anaesthetic medications

Intervention Type OTHER

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

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pharmacogenomic optimisation of anaesthetic medications

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No