euroendocrine and psychophysiological effects of the sentinel lymph node excision in melanoma patients under local anesthesia vs. general anesthesia.

• Conditions: C43; Malignant melanoma of skin

• Registration Number: DRKS00003076
• Lead Sponsor: Klinik und Poliklinik für Dermatologie, Venerologie und AllergologieUniversitätsklinikum Essen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-19
• Study Completion: 2017-04-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

patients with amalignant melanoma in AJCC (American Joint Committee on Cancer) stages I and II; age >18

Exclusion Criteria

Age <18 years, somatic illnesses, diabetes mellitus, intake of glucocorticoids or psychotropic medication during the last six months, and BMI = 30

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary Cortisol level (11:00 and 13:00 h) on preoperative days 3 [T1], and 2 [T2],, on the day of surgery (30 min before surgery [T3], at skin incision [T4], 20 min [T5] and 60 min [T6] after beginning of surgery, respectively), and twice (11:00 and 13:00 h) on postoperative day 2 [T7],, State-Trait-Anxiety Inventrory score (questionnaires; preoperative days 3 (T1) and 2 [T2],, 30 min before surgery [T3) as well as on postoperative day 2 [T7],;<br>Hospital Anxiety and Depression Scale score (questionnaires, preoperative day 3 [T1],)

Secondary Outcome Measures

Name	Time	Method
Vitals signs (heart rate, bloodpressure, respiratory rate) during surgical procedure (Monitoring screen, 30 min before surgery [T3], at skin incision [T4], 20 min [T5] and 60 min [T6] after beginning of surgery)