Investigation of nociceptive and antinociceptivemechanisms under anesthesia using fMRI, EEG and noxious reflexes

Phase 4

• Conditions: ociception under anesthesia in healthy participants

• Registration Number: DRKS00000663
• Lead Sponsor: Charité Campus Charité Mitte

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Study Completion: 2013-08-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

informed consent; age 18-60; no enrollment in other studies under the AMG (German medicinal products law)

Exclusion Criteria

any light or severe illness, especially even at the lightest stage: infections of the respiatory system, muscular diseases, diseases of the cns, chronical pain diseases, drug abuse, medication abuse; claustrophobia; increased risk of aspiration, especially adipositas (BMI > 30 kg/m2); pregnancy and lactation; history or family history of malign hyperthermia; history of family history of severe allergic reactions to propofol, remifentanil, soja, latex; placement in an institution on official order; implants, especially: pace makers, implanted cardioverters, cochlea implants, insulin pumps, nerve stimulators, vascular clips, cava filters, metal splints, screws, wires, plates; extensive or looped tattoos, unremovable piercings, other ferro-magnetic body onaments; unwillingness to comply to the filing and transmission of pseudonymous data about diseases in the scope of the clinical trial; actual of expected future dependence of the study personnell

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A dose-dependent reduction of BOLD-responses in pain-activated areas of the brain up to a complete cessation of signals by using propofol and remifentanil, imaged using functional magnetic resonance imaging

Secondary Outcome Measures

Name	Time	Method
Investigation whether clinical surrogate parameters for analgesia like movement on painful stimuli, heart rate, blood pressure, sweating, tearing, or parameters like EEG-parameters or nociceptive reflexes correlate with the suppression on pain-activated areas of the brain, imaged using magnetic resonance imaging