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Prospective observational study to analyse the association of non-genetic variables as well as genetic variants of candidate genes with the incidence of postoperative nausea and vomiting (PONV).
Background
Surgery and anesthesia are related to unwanted adverse events, side effects and postoperative discomfort. Postoperative nausea and vomiting are frequent and the question arises which patient is at specific risk for these sequelae. Some predisposing factors for PONV are well described, e.g. female sex, non-smoking status and postoperative opioids. Some drugs used for anesthesia as well as surgery related variables might induce PONV.
In this prospective association study patient related variables, surgical and anesthesia related variables as well as genetic variants of several candidate genes will be investigated in a well-described patient cohort presenting for scheduled surgery.
Objective
The aim of this study is to investigate a possible association of non-genetic variables and genetic variants with PONV.
Methods
Prospective association study performed in patients recovering form elective surgery and anesthesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All patients | Patients undergoing general anesthesia for elective surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Association study: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV | PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire. Patients with no PONV are compared to those with intermediate and severe PONV. Bariatric patients will not be included in this analysis. | perioperative period up to 48 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sex specific association analysis: Severity of PONV associated with genetic and non-genetic variables in males and females | PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome. questionnaire. Patients with no PONV are compared to those with intermediate and severe PONV | perioperative period up to 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria
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Patients scheduled for elective surgery
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| Name | Affiliation | Role |
|---|---|---|
| Ulrike Stamer, Prof. MD | Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern | Study Chair |
| Ulrike M Stamer, MD | Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31274544 | Derived | Stamer UM, Schmutz M, Wen T, Banz V, Lippuner C, Zhang L, Steffens M, Stuber F. A serotonin transporter polymorphism is associated with postoperative nausea and vomiting: An observational study in two different patient cohorts. Eur J Anaesthesiol. 2019 Aug;36(8):566-574. doi: 10.1097/EJA.0000000000001014. |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Whole blood (plasma and cells) or mucosal swab
| Association study in patients undergoing bariatric surgery: genetic and non-genetic variables associated with No PONV, Intermediate PONV and Severe PONV | PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire. Patients with no PONV are compared to those with intermediate and severe PONV | perioperative period up to 48 hours after surgery |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D009325 | Nausea |
| D012817 | Signs and Symptoms, Digestive |
| D014839 | Vomiting |