The influence of propofol and inhalational anesthetics on postoperative pain perception - QST and anesthetics

Phase 1

• Conditions: ISensory and pain perception in the skin of patients who receive anesthesia with two different anesthetics for elective surgery will be analyzed.

• Registration Number: EUCTR2009-016641-26-DE
• Lead Sponsor: ZARI - Univeristätsmedizin Göttingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-04-22
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Written informed consent obtained prior to study entry including informed consent for genetic research
2.Both genders (male and female)
3.Healthy adults aged =18 to < 65 years
4.Body weight 50 – 100 kg and BMI 18 – 28 kg/m²
5.Willingness to meet the study instructions and to co-operate with the study personell.
6.Female subjects will only be included if they have negative serum pregnancy test immediately before the general anesthesia.
7. Patients with ASA I or II classification who undergo elective surgery with planned surgical time of up to 150 minutes and minimal to moderate surgical trauma.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Involvement in the planning and conduct of the study (applies to staff directly employed at the study site / department)
2.Participation in a clinical study during the last 30 days or use of any other investigational or non-registered drug or vaccine during the study period or within 30 days preceding the first dose of study drugs
3.Age < 18 years or > 65 years
4.Any relevant clinical pathological which might affect the study measurements or pharmacokinetics or pharmacodynamics of the tested substances.
5.Any disease affecting central or peripheral nerve system.
6.Any disease in which use of the investigational medicinal products might be contraindicated.
7.Any acute inflammatory disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Comparison of the effect of inhalational anesthetics and propofol on postoperative pain threshold levels. ;Secondary Objective: The secondary objectives of the study are the analysis of postoperative sensory and pain perception in the skin following isoflurane and propofol anesthesia, time course of the development and persistance of postoperative hyperalgesia as well as postoperative analgesic consumption;Primary end point(s): The primary end-point will be the measurement of electrical current under which the stimulation of the sensory nerves is not any more tolerable by the patient.