Genetic Variants and Perioperative Morbidity and Mortality

Study Overview
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Brief Summary
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Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.

Detailed Description
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Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome. In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery. Objective The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants. Methods Prospective association study performed in two independent patient cohorts.

Official Title
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Genetic Variants and Perioperative Morbidity and Mortality

Conditions
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Anesthesia, Analgesia, Surgical Procedure, Operative

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Written informed consent Scheduled surgery Exclusion Criteria No informed consent Cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>Patients undergoing elective surgery with anesthesia | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting (PONV) | Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV | Up to 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related impairment after surgery | Measured by the International Pain Outcomes Questionnaire | up to 2 days after surgery | 
| Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery | Measured by the Brief Pain Inventory (BPI) | up to one year after surgery | 
| Cardio-vascular events after surgery | Measured by a score for major adverse cardiac events (MACE) | Up to 30 days after surgery | 
| Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery | Measured by the Brief Pain Inventory (BPI) | up to one year after surgery | 
| What influences pain related impairment after bariatric surgery | Measurement of patient reported outcome by the BPI (Brief Pain Inventory). | up to 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia recovery period, postoperative complications, pain, pain measurement, postoperative nausea and vomiting, quality of life, genetic association study