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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00003076

Enrollment

100

Registered

2014-02-19

Start date

2011-05-05

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C43

Interventions

Group 1: Sentinel lymph node excision in local anesthesia Group 2: Sentinel lymph node excision in general anesthesia

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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],; Hospital Anxiety and Depression Scale score (questionnaires, preoperative day 3 [T1],)	—

Measure

Time frame

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],; Hospital Anxiety and Depression Scale score (questionnaires, preoperative day 3 [T1],)

—

Secondary

Measure	Time frame
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)	—

Countries

Germany

Contacts

Public ContactIngo Stoffels

Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie

ingo.stoffels@uk-essen.de+4920172385366

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 18, 2026