Genetic Variants and Perioperative Morbidity and Mortality

Anesthesia Clinical Trial

Official title:

Genetic Variants and Perioperative Morbidity and Mortality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02124499
• Other study ID #: 041/09
• Status: Recruiting
• Start date: January 2011
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Insel Gruppe AG, University Hospital Bern
• Contact: Ulrike M Stamer, Prof. MD
• Phone: 0041-316329995
• Email: ulrike.stamer[@]dbmr.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Surgical Procedure, Operative

Locations

Country	Name	City	State
Switzerland	Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

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