Genetic Variants and Perioperative Morbidity and Mortality

Recruiting

• Conditions: Anesthesia; Analgesia; Surgical Procedure, Operative

• Registration Number: NCT02124499
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2014-04-04
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-14
• Last Update Posted: 2024-05-16
• Primary Completion: 2025-03
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

Inclusion Criteria

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

Exclusion Criteria

• No informed consent
• Cognitive impairment

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative nausea and vomiting (PONV)	Up to 48 hours after surgery	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

Secondary Outcome Measures

Name	Time	Method
Pain related impairment after surgery	up to 2 days after surgery	Measured by the International Pain Outcomes Questionnaire
Cardio-vascular events after surgery	Up to 30 days after surgery	Measured by a score for major adverse cardiac events (MACE)
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	Measured by the Brief Pain Inventory (BPI)
What influences pain related impairment after bariatric surgery	up to 1 year after surgery	Measurement of patient reported outcome by the BPI (Brief Pain Inventory).
Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery	up to one year after surgery	Measured by the Brief Pain Inventory (BPI)

Trial Locations

Locations (1)

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern; 🇨🇭 Bern, Switzerland