Patients Undergoing Anaesthesia InductionKEM-HENNCT06421181
Hemodynamic Effects of Anesthesia Induction
An observational study of Patients Undergoing Anaesthesia Induction, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients Undergoing Anaesthesia Induction
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 14 Jan 2025to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of advanced primary ovarian cancer will be screened prior to cytoreductive surgery in cooperation with the colleagues of gynaecological oncology. If the patients are eligible they will be informed to give consent.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Evangelische Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136
Aarne Feldheiser, M.D., PhD., +49201174 ext. 31001, a.feldheiser@kem-med.com
Stefan Boland, M.D., +49201174 ext. 31001, s.boland@kem-med.com
About this study
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.
Read the 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.
- Keywords
- Hemodynamic monitoring, Point-of-care ultrasound, Point-of-care echocardiography, Anaesthesia induction, Respiratory effects
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia
The heart rate will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia
The arterial blood pressures will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia
The stroke volume will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia
The echocardiographic feature of strain imaging for the analysis of contractile performance of the myocardium will be monitored prior to induction and after induction of anaesthesia to detect any changes
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Secondary outcomes (8)
Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography
The echocardiographic parameter will be monitored prior to induction and after induction of anaesthesia to detect any changes.
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of function of the cardiac valves assessed by a transthoracic echocardiography
The echocardiographic features will be monitored prior to induction and after induction of anaesthesia to detect any changes of the cardiac valve functions like increase of regurgitation
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes in percentage of the cardiocirculatory flow in an advanced hemodynamic monitoring device based on a pulse-contour methodology in a continuous fashion during induction of anaesthesia
The haemodynamic features will be monitored prior to the start of induction up to the end of induction of anaesthesia to detect any changes
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound
The ultrasound features will be monitored prior to induction and after induction of anaesthesia to detect any changes
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Mean systemic filling pressure (MSFP)
The MSFP will be determined based on the stop-flow-methodology to determine additionally venous return characteristics
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Baroreceptor sensitivity (BRS)
BRS will be determined to analyse the impact of drugs of anaesthesia induction on the vegetative nervous system. The assessment is based on invasive measurement of the arterial blood pressure in combination with the electrocardiogram
Measured: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start14 Jan 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Anaesthesia InductionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Responsible party
- Sponsor
- Investigators
- Aarne Feldheiser, M.D., PhD., Principal investigator, Evangelische Kliniken Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421181
- Sponsor's protocol ID
- KEM-HEN
- Acronym
- KEM-HEN
- Status last verified
- Jan 2025
- First submitted
- 26 Apr 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29369117Ripolles-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.
PubMed 26873025Sessler 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.
PubMed 30916004Kouz 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.
PubMed 36008202Futier 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.
PubMed 28973220Nicklas 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.
PubMed 32711724Saugel 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.
PubMed 33523352Middel 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.
PubMed 37682496Feldheiser 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.
PubMed 37265333
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effects of Anesthesia Induction
- ClinicalTrials.gov ID
- NCT06421181
- Acronym / sponsor ID
- KEM-HEN / KEM-HEN
- Keywords
- Hemodynamic monitoring, Point-of-care ultrasound, Point-of-care echocardiography, Anaesthesia induction, Respiratory effects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Collaborators
- Heinrich-Heine University, Duesseldorf
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of advanced primary ovarian cancer will be screened prior to cytoreductive surgery in cooperation with the colleagues of gynaecological oncology. If the patients are eligible they will be informed to give consent.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The heart rate will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Longitudinal change of arterial blood pressure assessed in percentaqes during the induction of anaesthesia
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The arterial blood pressures will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Longitudinal change of stroke volume assessed in percentaqes during the induction of anaesthesia
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The stroke volume will be monitored continuously to detect any change of it during the induction of anaesthesia. The change will be described in percentages.
Longitudinal change of myocardial strain imaging assessed by transthoracic echocardiography during the induction of anaesthesia
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
The echocardiographic feature of strain imaging for the analysis of contractile performance of the myocardium will be monitored prior to induction and after induction of anaesthesia to detect any changes
8 secondary outcomes
Changes in percentages in a comprehensive echocardiographic assessment of the right ventricle and atrium
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of the left ventricular and atrial volume in percentages assessed by a transthoracic echocardiography
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of the left ventricular systolic and diastolic function in percentages assessed by a transthoracic echocardiography
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of function of the cardiac valves assessed by a transthoracic echocardiography
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes in percentage of the cardiocirculatory flow in an advanced hemodynamic monitoring device based on a pulse-contour methodology in a continuous fashion during induction of anaesthesia
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Changes of flow profiles of the splanchnic vessels as well as peripheral arteries determined by ultrasound
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Mean systemic filling pressure (MSFP)
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Baroreceptor sensitivity (BRS)
Time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 29369117Chong 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.
- Background: PubMed 26873025Ripolles-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.
- Background: PubMed 30916004Sessler 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.
- Background: PubMed 36008202Kouz 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.
- Background: PubMed 28973220Futier 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.
- Background: PubMed 32711724Nicklas 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.
- Background: PubMed 33523352Saugel 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.
- Results publication: PubMed 37682496Middel 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.
- Results publication: PubMed 37265333Feldheiser 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.
- Individual participant dataSharing planned: No
Related trials for Patients Undergoing Anaesthesia Induction
RecruitingObservational study
Carotid Doppler Changes After Passive Leg Raising for Prediction of Post-Induction Hypotension in Gastrointestinal Tumor Surgery
Post-induction Hypotension (PIH), Gastrointestinal Tumor Surgery
Not yet recruitingPhase 4
Effects of Ondansetron Timing During Spinal Anesthesia for Urologic Surgery
Spinal Anesthesia-Induced Hypotension, Cerebral Oxygenation
Not yet recruiting
Pre-induction Norepinephrine in Septic Patients Undergoing Surgery
Sepsis, Hypotension
RecruitingObservational study
Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG
Coronary Artery Disease
Not yet recruitingPhase 4
Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
Preeclampsia, Spinal Anesthesia-Induced Hypotension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aarne Feldheiser, M.D., PhD. principal investigator
Evangelische Kliniken Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Anaesthesia Induction, run by Kliniken Essen-Mitte at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aarne Feldheiser, M.D., PhD. (+49201174 ext. 31001, a.feldheiser@kem-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Longitudinal change of heart rate assessed in percentages during the induction of anaesthesia (time frame: Time from the start of anaesthesiological monitoring up to start of surgical measures, up to four hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421181, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025; AzTrials last refreshed its copy on 2 Nov 2026.