Genetic Variants and Perioperative Morbidity and Mortality

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Anesthesia; Surgical Procedure, Operative

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.

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Ulrike M Stamer, Prof. MD; Phone Number: 0041-316329995; Email: ulrike.stamer@dbmr.unibe.ch
• Study Contact Backup: Name: Markus Lüdi, MD; Phone Number: 0041-316323965; Email: markus.luedi2@insel.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern
    • Contact: Frank Stüber, Professor MD; Phone Number: 041-316322483; Email: frank.stueber@insel.ch
    • Sub-Investigator: Ulrike M Stamer, MD
    • Contact: Anneliese Hoffmann, PhD; Phone Number: 0041-316328872; Email: lan.zhang@unibe.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery

Description

Inclusion Criteria:

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

Exclusion Criteria

• No informed consent
• Cognitive impairment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
All patients; Patients undergoing elective surgery with anesthesia

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Ulrike M Stamer, MD, Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; Study Chair: Frank Stüber, Prof. MD, Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2011
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 4, 2014
• First Submitted That Met QC Criteria: April 24, 2014
• First Posted (Estimated): April 28, 2014

Study Record Updates

• Last Update Posted (Estimated): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: pain; quality of life; pain measurement; postoperative nausea and vomiting; postoperative complications; anesthesia recovery period; genetic association study
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Signs and Symptoms, Digestive; Neurobehavioral Manifestations; Perceptual Disorders; Vomiting; Nausea; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Postoperative Nausea and Vomiting; Agnosia; Postoperative Complications
• Other Study ID Numbers: 041/09