Safety of sedation in gastrointestinal endoscopy: non-inferiority of safety in ESA (Endoscopic Sedation Assessment) Class A versus ASA (American Society of Anesthesiologists) patients 2 - Validation of a new classification for the assessment of sedation-associated risk in gastrointestinal endoscopy: The ESA (endoscopic sedation risk assessment) classification

Safety of sedation in gastrointestinal endoscopy: non-inferiority of safety in ESA (Endoscopic Sedation Assessment) Class A versus ASA (American Society of Anesthesiologists) patients 2 - Validation of a new classification for the assessment of sedation-associated risk in gastrointestinal endoscopy: The ESA (endoscopic sedation risk assessment) classification - ProSed4-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00027246

Enrollment

30000

Registered

2023-11-23

Start date

2025-06-01

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

T81.9

Interventions

Group 1: Observational study/single-arm: Type and incidence of sedation-associated complications in relation to the established risk classification (ASA) compared to the new classification (ESA)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Sedation in GI endoscopy, ESA A, consent present

Exclusion criteria

Exclusion criteria: Pregnancy, breastfeeding, lack of consent, lack of capacity to consent, ASA 1, ESA B, emergency endoscopy

Design outcomes

Primary

Measure	Time frame
Occurrence of sedation-associated complications	—

Secondary

Measure	Time frame
Type of sedation-associated complications	—

Countries

Germany

Contacts

Public ContactAngelika Behrens

Evangelische Elisabeth Klinik

angelika.behrens@jsd.de030-2506250

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026