to study search History

Safe and sustainable balanced anesthesia – identifying potentials in daily clinical routine

Organizational Data

DRKS-ID:
DRKS00029400
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-01-20
Last update in DRKS:
2023-05-15
Registration type:
Prospective

Acronym/abbreviation of the study

SAFE-SUSTAIN

URL of the study

No Entry

Brief summary in lay language

This study aims to investigate which ventilation parameters anesthesiologists choose, how much narcotic gas is used and how that influences the patients' well-being as well as economical and ecological factors. In addition, patient specific data will be compared to an optimized simulated anesthesia in order to examine potential for improvement.

Brief summary in scientific language

This multicenter prospective observational study aims to investigate which fresh gas flow (FGF) settings are used in daily clinical routine during anesthesia induction and maintenance and determine how much narcotic gas is used. We aim to investigate the safety of applied FGF settings by assessing the achieved minimal alveolar concentration (MAC), depth of anaesthesia by neuromonitoring and hemodynamic stability. Further analyses include a comparison of different sevoflurane consumption measurements and a comparison of sevoflurane consumption during anesthesia induction in the real-world clinical setting vs. an optimized simulated setting. We aim to determine an optimal induction algorithm for balanced anesthesia cases, which is safe and sustainable.

Health condition or problem studied

Free text:
balanced anesthesia
Free text:
inhalation anesthesia
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Surgical patients receiving general anesthesia at RWTH Aachen University and other interested German hospitals

Endpoints

Primary outcome:
Sevoflurane consumption in ml during induction of anesthesia (cumulative amount in the first 7 minutes after opening of vaporizer 1)
Secondary outcome:
- Sevoflurane consumption in ml during maintenance - Ventilation settings: Fresh gas flow, Vaporizer setting, Fraction of inspiratory and expiratory oxygen, endtidal sevoflurane concentration - minimal alveolar concentration (MAC) - Ventilation complications: laryngospasm, bronchospasm - Narcotic depth: neuromonitoring, need for additional propofol bolus - Hemodynamic stability: mean arterial blood pressure, need for vasopressors, bradycardia/tachycardia - Economic efficiency: Cost savings - Sustainability: CO2 equivalents

Study Design

Purpose:
Other
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • Medical center St. Elisabeth Hospital Gütersloh Gütersloh
  • University medical center Uniklinik RWTH Aachen Aachen
  • Medical center Christliches Krankenhaus Quakenbrück Quakenbrück
  • Medical center Marienhospital Vechta Vechta

Recruitment period and number of participants

Planned study start date:
2023-05-10
Actual study start date:
2023-05-11
Planned study completion date:
2024-05-15
Actual Study Completion Date:
No Entry
Target Sample Size:
251
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
• ≥18 years • ASAI-II • MET≥4 • General anesthesia with sevoflurane • Elective surgery with intubation

Exclusion Criteria

• Not willing to participate • not able to provide informed consent • pregnancy • BMI≥30kg/m2 and <18kg/m2 • severe respiratory disease • single lung ventilation • cardiac and thoracic surgery • extracorporeal membrane oxygenation • emergency surgery

Addresses

Primary Sponsor

Klinik für Anästhesiologie, Uniklinikum RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+49 241 8036929
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Anästhesiologie, Uniklinikum RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für AnästhesiologieUniklinik RWTH Aachen
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Anästhesiologie, Uniklinikum RWTH Aachen
Dr. med. Linda Grüßer
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Klinik für Anästhesiologie, Uniklinik RWTH Aachen
Pauwelsstraße 30
52074 Aachen
Germany
Telephone:
+ 49 241 80 88179
Fax:
+49 241 80 82406
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum Aachen
Pauwelsstr. 30
52074 Aachen
Germany
Telephone:
+49-241-8089963
Fax:
+49-241-8082012
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-07-11
Ethics committee number:
EK 246/22
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-08-29

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry