Clinical trial NCT02124499: Genetic Variants and Perioperative Morbidity and Mortality
Official title: Genetic Variants and Perioperative Morbidity and Mortality
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia
Analgesia
Surgical Procedure, Operative
Keywords: anesthesia recovery period
postoperative complications
pain
pain measurement
postoperative nausea and vomiting
quality of life
genetic association study
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective surgery

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Written informed consent
* Scheduled surgery

Exclusion Criteria

* No informed consent
* Cognitive impairment

Primary outcomes:
measure: Postoperative nausea and vomiting (PONV)
timeFrame: Up to 48 hours after surgery
Secondary outcomes:
measure: Pain related impairment after surgery
timeFrame: up to 2 days after surgery
measure: Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery
timeFrame: up to one year after surgery
measure: Cardio-vascular events after surgery
timeFrame: Up to 30 days after surgery
measure: Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery
timeFrame: up to one year after surgery
measure: What influences pain related impairment after bariatric surgery
timeFrame: up to 1 year after surgery
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
Study officials:
affiliation: Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern
name: Frank Stüber, Prof. MD
role: STUDY_CHAIR
affiliation: Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
name: Ulrike M Stamer, MD
role: PRINCIPAL_INVESTIGATOR
References: