Genetic Variants and Non-genetic Variables and Postoperative Nausea and Vomiting
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|ClinicalTrials.gov Identifier: NCT03490175|
Recruitment Status : Recruiting
First Posted : April 6, 2018
Last Update Posted : April 6, 2018
|Condition or disease|
|Anesthesia Analgesia Surgical Procedure, Operative|
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.
The aim of this study is to investigate a possible association of non-genetic variables and genetic variants with PONV.
Prospective association study performed in patients recovering form elective surgery and anesthesia.
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Genetic Variants and Non-genetic Variables Associated With Postoperative Nausea and Vomiting (PONV)|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Patients undergoing general anesthesia for elective surgery
- Incidence of postoperative nausea and vomiting with patients allocated to the groups No PONV, Intermediate PONV and Severe PONV [ Time Frame: perioperative period up to 48 hours after surgery ]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
- Sex specific analysis of PONV [ Time Frame: perioperative period up to 48 hours after surgery ]PONV composite outcome measured by episodes of vomiting + and PONV composite outcome measured by episodes of vomiting and nausea + need for antiemetic treatment + results of a patient reported outcome questionnaire
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490175
|Contact: Ulrike M Stamer, Prof. MDemail@example.com|
|Contact: Frank Stüber, Prof. MDfirstname.lastname@example.org|
|Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern||Recruiting|
|Bern, Switzerland, 3010|
|Contact: Ulrike Stamer, Prof. MD 041-316329995 email@example.com|
|Contact: Christoph Lippuner, PhD 0041-316320826 firstname.lastname@example.org|
|Principal Investigator: Ulrike M Stamer, MD|
|Study Chair:||Ulrike Stamer, Prof. MD||Department of Anaestheisology and Pain Medicine, Inselspital, University of Bern|
|Principal Investigator:||Ulrike M Stamer, MD||Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern|