Hemodynamic Effects of Anesthesia Induction

NCT ID: NCT06421181

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2026-06-30

Brief Summary

The idea of that project is to characterize the hemodynamic changes of a daily used clinical intervention (induction of anesthesia) in a highly controlled environment by two hemodynamic monitoring devices. The aim is an advanced hemodynamic profiling of this intervention and additionally screen for changes in flow patterns in an exploratory fashion.

Both devices complement one another in their hemodynamic profiling ability. One device is a continuous monitoring with instant traceable changes and the other an intermittent point-of-care ultrasound/echocardiography device with advanced possibilities for differential diagnostics.

A second purpose is to test the possibility to implement advanced echocardiography in a point-of-care approach during anaesthesia induction and evaluate the time and quality of a comprehensive analysis by a not-certified anaesthetists with an echocardiography device with features of artificial intelligence versus a certified expert.

Detailed Description

Mortality after surgery is still high and high-risk procedures are associated to high postoperative complication rates. For hemodynamic monitoring, a meta-analysis showed a reduction in mortality and especially for the esophageal Doppler a reduction in postoperative complications. However, the effects reducing mortality and morbidity have to be considered as low. Probably, this is the reason why daily clinical implementation rates of hemodynamic monitoring are low, too.

However, hemodynamic studies only focus on intraoperative optimization, but recent publications suggested that taking preoperative individual hemodynamic values for arterial blood pressure and cardiac index as targets for optimization provides advanced therapeutic options. Lastly, both studies do not provide data about the preoperative values and their changes during the induction of anesthesia.

Our own data confirm that the induction of anesthesia, the establishment of a working epidural and the surgical incision of the abdomen leads to decreased cardiac index and markers of inotropy in otherwise cardiovascular healthy patients. However, the intervention studies and our own data strongly suggest that starting hemodynamic monitoring after the induction of anesthesia or the surgical incision may foreclose that the clinician can guide the hemodynamic therapy towards individualized goals. Additionally, the corrective treatment in this scenario could be different from just vasopressors.

Nevertheless, in contrast to our own data a recent study showed that hypotension in the post-induction period is primarily associated with a decreased vascular tone due to anesthetic agents, suggesting that the appropriate treatment is vasopressors.

A detailed hemodynamic profiling of non-cardiac patients undergoing high-risk cancer surgery prior, during and after the induction of anaesthesia may provide new insights about the effects of anaesthetic drugs, positive pressure ventilation, and changes of sympathetic tone.

Conditions

Patients Undergoing Anaesthesia Induction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing elective laparotomy in the hospital Evangelische Kliniken Essen-Mitte
• Due to the invasiveness of the planned surgery there is an indication for an arterial and central-venous line as well as an peridural catheter

Exclusion Criteria

• Age < 18 years
• Lack of written informed consent
• Insufficient language skills
• Unwillingness to have pseudonymized disease data stored at the study site and lack of consent to share anonymized data as part of the clinical trial
• American society of anaesthesiologists physical status higher as grade 3
• congestive heart failure with a grade of 2 or higher according to the New York heart association (NYHA)
• Ischemic cardiopathy with a grade of 2 or higher according to the Canadian cardiovascular society (CCS)
• Known severe valve pathologies of the heart
• Chronic kidney disease with dependency of hemodialysis
• Atrial fibrillation ora trail flutter
• Pulmonary hypertension

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: collaborator

Kliniken Essen-Mitte

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aarne Feldheiser, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Evangelische Kliniken Essen-Mitte

Locations

Evangelische Kliniken Essen-Mitte

Essen, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Aarne Feldheiser, M.D., PhD.

Role: CONTACT

a.feldheiser@kem-med.com

+49201174 ext. 31001

Stefan Boland

Role: CONTACT

s.boland@kem-med.com

+49201174 ext. 31001

Facility Contacts

Aarne Feldheiser, M.D., PhD.

Role: primary

a.feldheiser@kem-med.com

+49201174 ext. 31001

Stefan Boland, M.D.

Role: backup

s.boland@kem-med.com

+49201174 ext. 31001

References

Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.

Reference Type: BACKGROUND

PMID: 29369117 (View on PubMed)

Ripolles-Melchor J, Casans-Frances R, Espinosa A, Abad-Gurumeta A, Feldheiser A, Lopez-Timoneda F, Calvo-Vecino JM; EAR Group, Evidence Anesthesia Review Group. Goal directed hemodynamic therapy based in esophageal Doppler flow parameters: A systematic review, meta-analysis and trial sequential analysis. Rev Esp Anestesiol Reanim. 2016 Aug-Sep;63(7):384-405. doi: 10.1016/j.redar.2015.07.009. Epub 2016 Feb 10. English, Spanish.

Reference Type: BACKGROUND

PMID: 26873025 (View on PubMed)

Sessler DI, Bloomstone JA, Aronson S, Berry C, Gan TJ, Kellum JA, Plumb J, Mythen MG, Grocott MPW, Edwards MR, Miller TE; Perioperative Quality Initiative-3 workgroup; POQI chairs; Miller TE, Mythen MG, Grocott MP, Edwards MR; Physiology group; Preoperative blood pressure group; Intraoperative blood pressure group; Postoperative blood pressure group. Perioperative Quality Initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth. 2019 May;122(5):563-574. doi: 10.1016/j.bja.2019.01.013. Epub 2019 Feb 27.

Reference Type: BACKGROUND

PMID: 30916004 (View on PubMed)

Kouz K, Wegge M, Flick M, Bergholz A, Moll-Khosrawi P, Nitzschke R, Trepte CJC, Krause L, Sessler DI, Zollner C, Saugel B. Continuous intra-arterial versus intermittent oscillometric arterial pressure monitoring and hypotension during induction of anaesthesia: the AWAKE randomised trial. Br J Anaesth. 2022 Oct;129(4):478-486. doi: 10.1016/j.bja.2022.06.027. Epub 2022 Aug 23.

Reference Type: BACKGROUND

PMID: 36008202 (View on PubMed)

Futier E, Lefrant JY, Guinot PG, Godet T, Lorne E, Cuvillon P, Bertran S, Leone M, Pastene B, Piriou V, Molliex S, Albanese J, Julia JM, Tavernier B, Imhoff E, Bazin JE, Constantin JM, Pereira B, Jaber S; INPRESS Study Group. Effect of Individualized vs Standard Blood Pressure Management Strategies on Postoperative Organ Dysfunction Among High-Risk Patients Undergoing Major Surgery: A Randomized Clinical Trial. JAMA. 2017 Oct 10;318(14):1346-1357. doi: 10.1001/jama.2017.14172.

Reference Type: BACKGROUND

PMID: 28973220 (View on PubMed)

Nicklas JY, Diener O, Leistenschneider M, Sellhorn C, Schon G, Winkler M, Daum G, Schwedhelm E, Schroder J, Fisch M, Schmalfeldt B, Izbicki JR, Bauer M, Coldewey SM, Reuter DA, Saugel B. Personalised haemodynamic management targeting baseline cardiac index in high-risk patients undergoing major abdominal surgery: a randomised single-centre clinical trial. Br J Anaesth. 2020 Aug;125(2):122-132. doi: 10.1016/j.bja.2020.04.094.

Reference Type: BACKGROUND

PMID: 32711724 (View on PubMed)

Saugel B, Bebert EJ, Briesenick L, Hoppe P, Greiwe G, Yang D, Ma C, Mascha EJ, Sessler DI, Rogge DE. Mechanisms contributing to hypotension after anesthetic induction with sufentanil, propofol, and rocuronium: a prospective observational study. J Clin Monit Comput. 2022 Apr;36(2):341-347. doi: 10.1007/s10877-021-00653-9. Epub 2021 Feb 1.

Reference Type: BACKGROUND

PMID: 33523352 (View on PubMed)

Middel C, Stetzuhn M, Sander N, Kalkbrenner B, Tigges T, Pielmus AG, Spies C, Pietzner K, Klum M, von Haefen C, Hunsicker O, Sehouli J, Konietschke F, Feldheiser A. Perioperative advanced haemodynamic monitoring of patients undergoing multivisceral debulking surgery: an observational pilot study. Intensive Care Med Exp. 2023 Sep 8;11(1):61. doi: 10.1186/s40635-023-00543-1.

Reference Type: RESULT

PMID: 37682496 (View on PubMed)

Feldheiser A, Juhl-Olsen P, Nordine M, Stetzuhn M, Wiegank L, Knebel F, Treskatsch S, Berger C. A comprehensive echocardiographic analysis during simulated hypovolaemia: An observational study. Eur J Anaesthesiol. 2023 Aug 1;40(8):578-586. doi: 10.1097/EJA.0000000000001863. Epub 2023 Jun 1.

Reference Type: RESULT

PMID: 37265333 (View on PubMed)

Other Identifiers

KEM-HEN

Identifier Type: -

Identifier Source: org_study_id