Genetic Variants and Perioperative Morbidity and Mortality

NCT02124499 | Recruiting DMC

• 1 other identifier: 041/09
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pain related impairment after surgery

  up to 2 days after surgery

• Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery

  up to one year after surgery

• Cardio-vascular events after surgery

  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

  up to one year after surgery

• What influences pain related impairment after bariatric surgery

  up to 1 year after surgery

Study Arms (1)

All patients

Patients undergoing elective surgery with anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective surgery

You may qualify if:

• years and older
• Written informed consent
• Scheduled surgery

You may not qualify if:

• No informed consent
• Cognitive impairment

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, 3010, Switzerland

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

whole blood (plasma and cells) or mucosal swab

MeSH Terms

Conditions

Agnosia; Postoperative Complications; Pain; Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Study Officials

• Frank Stüber, Prof. MD

  Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern

  STUDY CHAIR

• Ulrike M Stamer, MD

  Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulrike M Stamer, Prof. MD

CONTACT

0041-316329995; ulrike.stamer@dbmr.unibe.ch

Markus Lüdi, MD

CONTACT

0041-316323965; markus.luedi2@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2014
• First Posted: April 28, 2014
• Study Start: January 2, 2011
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

CH (1)