Post-induction HypotensionNCT07785635
Evaluation of the Relation Between Patient Fasting Time and the Occurrence of PIH (Post Induction Hypotension)
An observational study of Post-induction Hypotension, run by University Hospital Ostrava at 1 site in Czechia.
Trial summary
This monocentre prospective trial aims to evaluate the relationship between fasting time and the occurence of PIH (post-induction hypotension). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-induction Hypotension
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 1 May 2025to Sep 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing surgery in general anaesthesia
Who may be able to join
- Age ≥ 18 years
- Patients undergoing planned surgical or diagnostic procedure
- Intubation under general anaesthesia
Who cannot join
- Pregnancy
- Disagreement with participation in the study
- Bowel preparation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, 70852
Jiří Hynčica, 0042059737 ext. 2587, jiri.hyncica@fno.cz
Ondřej Jor, MD, PhD, MBA
About this study
Official title: Evaluation of the Relation Between Patient Fasting Time and the Occurrence of PIH (Post Induction Hypotension) - Prospective Trial
This monocentre prospective trial aims to evaluate the relationship between fasting time and the occurence of PIH (post-induction hypotension).
Read the detailed description
A decrease in blood pressure (BP) after induction of general anesthesia (GA) is a common phenomenon. The etiology is multifactorial (vasodilatory and dále negative inotropic effects of anaesthetics, reduction in sympathetic tone, the effect of positive pressure ventilation and others). Relative hypovolemia due to patient fasting is one of the factors that can have a significant influence on the decrease in blood pressure after induction of GA. Different lengths of fasting may thus lead to variations in both the incidence of hypotension after induction of GA (post-induction hypotension - PIH) and the severity of the BP drop.
- Conditions
- Post-induction Hypotension
- Keywords
- General anaesthesia, Post-induction hypotension, Fasting, Decrease of blood pressure
- Medical subject headings
- Fasting
What is being measured
The primary outcome is the main question the study is designed to answer.
Post induction hypotension (PIH)
The incidence of the post induction hypotension (PIH) will be assessed in the study subjects.
Measured: 1 month
Seriousness of post induction hypotension (PIH)
Seriousness of post induction hypotension (PIH) will be assessed to determine whether patients with longer fasting time experience a significant reduction of blood pressure after induction of general anaesthesia.
Measured: 1 month
Comparison of other PIH risk factors
The risk factors such as comordibity, chronic medication, type and doses of induction drugs will be compared.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start1 May 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-induction HypotensionStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ostrava
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ondřej Jor, MD, PhD, MBA, Principal investigator, University Hospital Ostrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785635
- Sponsor's protocol ID
- FNO-KARIM-PIH
- Status last verified
- Aug 2026
- First submitted
- 20 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
Publications
Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
PubMed 28974066
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relation Between Patient Fasting Time and the Occurrence of PIH (Post Induction Hypotension) - Prospective Trial
- ClinicalTrials.gov ID
- NCT07785635
- Acronym / sponsor ID
- FNO-KARIM-PIH
- Conditions
- Post-induction Hypotension
- Keywords
- General anaesthesia, Post-induction hypotension, Fasting, Decrease of blood pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital OstravaUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 25 Aug 2026 (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.
This monocentre prospective trial aims to evaluate the relationship between fasting time and the occurence of PIH (post-induction hypotension).
Detailed description
A decrease in blood pressure (BP) after induction of general anesthesia (GA) is a common phenomenon. The etiology is multifactorial (vasodilatory and dále negative inotropic effects of anaesthetics, reduction in sympathetic tone, the effect of positive pressure ventilation and others). Relative hypovolemia due to patient fasting is one of the factors that can have a significant influence on the decrease in blood pressure after induction of GA. Different lengths of fasting may thus lead to variations in both the incidence of hypotension after induction of GA (post-induction hypotension - PIH) and the severity of the BP drop.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery in general anaesthesia
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients undergoing planned surgical or diagnostic procedure
- Intubation under general anaesthesia
Key exclusion criteria (3 listed)
- Pregnancy
- Disagreement with participation in the study
- Bowel preparation
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
Post induction hypotension (PIH)
Time frame: 1 month
The incidence of the post induction hypotension (PIH) will be assessed in the study subjects.
Seriousness of post induction hypotension (PIH)
Time frame: 1 month
Seriousness of post induction hypotension (PIH) will be assessed to determine whether patients with longer fasting time experience a significant reduction of blood pressure after induction of general anaesthesia.
Comparison of other PIH risk factors
Time frame: 1 month
The risk factors such as comordibity, chronic medication, type and doses of induction drugs will be compared.
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 25 Aug 2026.
- Background: PubMed 28974066Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers. The data may be provided upon request.
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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.
Ondřej Jor, MD, PhD, MBA principal investigator
University Hospital Ostrava
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 Post-induction Hypotension, run by University Hospital Ostrava at 1 site in Czechia.
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 3 inclusion and 3 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 25 Aug 2026. 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 Czechia. 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 Jiří Hynčica (0042059737 ext. 2587, jiri.hyncica@fno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post induction hypotension (PIH) (time frame: 1 month). The study lists 3 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 NCT07785635, which also lists 1 linked publication.
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 25 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.