Anesthesia Clinical Trial
Official title:
Genetic Variants and Perioperative Morbidity and Mortality
NCT number | NCT02124499 |
Other study ID # | 041/09 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 2011 |
Est. completion date | June 2026 |
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.
Status | Recruiting |
Enrollment | 20000 |
Est. completion date | June 2026 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 18 years and older - Written informed consent - Scheduled surgery Exclusion Criteria - No informed consent - Cognitive impairment |
Country | Name | City | State |
---|---|---|---|
Switzerland | Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern | Bern |
Lead Sponsor | Collaborator |
---|---|
Insel Gruppe AG, University Hospital Bern |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Pain related impairment after surgery | Measured by the International Pain Outcomes Questionnaire | up to 2 days after surgery | |
Secondary | 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 | |
Secondary | Cardio-vascular events after surgery | Measured by a score for major adverse cardiac events (MACE) | Up to 30 days after surgery | |
Secondary | 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 | |
Secondary | 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 |
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