Hypotension During SurgeryNCT07022210
Incidence of Hypotension in the Post-anesthesia Care Unit (PACU).
An observational study of Hypotension During Surgery and Surgery-Complications, run by Tomas Bata Hospital, Czech Republic at 1 site in Czechia.
Trial summary
The perioperative period poses a heightened risk of complications for patients, including hypotension. While the issue of intraoperative hypotension is well-documented in medical literature, the occurrence and causes of hypotension in the post-anesthesia care unit often receive less attention. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypotension During Surgery, Surgery-Complications
- How many people
- 100 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Jun 2025to 1 May 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 to 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients meeting the inclusion criteria, aged 18 to 105 years, with an indicated hospitalization at a diagnostic-therapeutic unit (DTU).
Who may be able to join
- patients over 18 years old
- patients undergoing a procedure under general anesthesia
- patients who have consented to data processing
- postoperative stay in PACU
Who cannot join
- patients younger than 18 years old.
- patients transferred directly to the ICU/Anesthesiology and Resuscitation Department after surgery without staying in the recovery room.
- patients with incomplete medical documentation or missing blood pressure values in the recovery room.
- patients with a pre-existing diagnosis of resistant hypotension or unstable hemodynamics before surgery
- patients with a history of long-term use of anxiolytics, antipsychotics, or other psychotropic medications that may affect cognitive function, emotional state, or predictive outcomes
- patient refusal to participate in the study (including cases where they initially consented), with an emphasis on respecting patient autonomy
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
Tomas Bata regional Hospital
Zlín, 76001
About this study
The perioperative period poses a heightened risk of complications for patients, including hypotension. While the issue of intraoperative hypotension is well-documented in medical literature, the occurrence and causes of hypotension in the post-anesthesia care unit often receive less attention. This phase of postoperative care, however, is vital for ensuring patient stability and preventing severe consequences. Failure to identify and manage a drop in blood pressure can lead to hypoperfusion of critical organs, increasing the risk of morbidity and mortality. The aim of this study is to examine the frequency of hypotension in the post-anesthesia care unit-defined as systolic blood pressure <90 mmHg or a drop of more than 20% from baseline-and to identify factors contributing to its development.
Read the detailed description
The perioperative period is a critical time for patients, marked by an increased risk of various complications, including hypotension. While intraoperative hypotension is extensively studied in medical literature, the occurrence and underlying causes of hypotension in the post-anesthesia care unit (PACU) often remain overlooked. This phase of postoperative care is essential for stabilizing the patient and preventing severe outcomes. A failure to identify and adequately address a drop in blood pressure during this time can result in hypoperfusion of vital organs, increasing the likelihood of morbidity and mortality.
Hypotension in the PACU is defined as a systolic blood pressure below 90 mmHg or a decrease exceeding 20% compared to the patient's baseline measurements. The aim of this research is to explore the prevalence of hypotension in the PACU and to analyze the factors contributing to its occurrence. By improving the understanding of this issue, the study seeks to enhance patient outcomes through timely identification and management of hypotension in this crucial phase of care.
- Conditions
- Hypotension During Surgery, Surgery-Complications
- Keywords
- hypotension, post-anesthesia care unit, surgery, adult
- Medical subject headings
- Hypotension
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension in the post-anesthesia care unit (PACU).
Hypotension is defined as systolic blood pressure <90 mmHg or a decrease of more than 20% from baseline values.
Measured: 0. postoperative day
Secondary outcomes (18)
Duration of the operation
Duration of the surgical procedure as a risk factor for the development of postoperative hypotension. The duration will be recorded in minutes.
Measured: 0. postoperative day
ASA classification (American Society of Anesthesiologists classification).
ASA classification as a risk factor for the development of postoperative hypotension.
ASA I: A normal healthy patient with no systemic disease. ASA II: A patient with mild systemic disease that does not limit daily activities (e.g., well-controlled diabetes or hypertension).
ASA III: A patient with severe systemic disease that limits daily activities but is not incapacitating (e.g., poorly controlled diabetes or hypertension, chronic obstructive pulmonary disease).
ASA IV: A patient with severe systemic disease that is a constant threat to life (e.g., unstable angina, symptomatic heart failure).
ASA V: A moribund patient who is not expected to survive without surgery (e.g., ruptured abdominal aneurysm).
Measured: 0. postoperative day
Type of anesthesia.
The type of anesthesia used: general, regional, and/or peripheral nerve block.
Measured: 0. postoperative day
Blood loss during the operation
Blood loss during the surgical procedure, as documented in the surgical protocol.
Measured: 0. postoperative day
Fluid balance during the surgery
Fluid intake and output during surgery, measured in milliliters.
Measured: 0. postoperative day
Surgical specialty
Surgical specialties: neurosurgery, urology, gynecology, abdominal surgery, orthopedics
Measured: 0. postoperative day
Fluid administration in the recovery room.
Administration of a crystalloid or colloid bolus to augment intravascular volume.
Measured: 0. postoperative day
Administration of vasopressors.
In cases of severe hypotension, vasopressor administration (e.g., ephedrine, phenylephrine, norepinephrine) may be required to ensure adequate perfusion of vital organs.
Measured: 0. postoperative day
Blood pressure monitoring.
Repeated blood pressure measurement every 5 minutes.
Measured: 0. postoperative day
Heart rate monitoring.
Continuous heart rate monitoring.
Measured: 0. postoperative day
Patient repositioning
The Trendelenburg position (legs elevated above the head) can help increase venous return and consequently blood pressure. It will not be performed in surgeries involving the lower extremities.
Measured: 0. postoperative day
Transfer of the patient to the ICU due to hemodynamic instability
If hypotension does not improve despite repeated therapeutic interventions, escalation of care to the ICU may be necessary.
Measured: 0. postoperative day
Postoperative nausea and vomiting
Inadequate gastrointestinal perfusion can lead to nausea and vomiting, complicating the patient's recovery.
Measured: 0. postoperative day
Impaired diuresis (oliguria, anuria)
Oliguria is a medical term referring to low urine output, typically defined as producing less than 400-500 mL of urine per day in adults.
Anuria is a medical condition characterized by the absence or near absence of urine production, typically defined as less than 100 mL of urine per day.
Measured: 0. postoperative day
Impaired consciousness - GCS
The Glasgow Coma Scale (GCS) is a clinical tool used to assess a person's level of consciousness after a brain injury. It evaluates three responses: eye opening, verbal response, and motor response, with scores ranging from 3 (deep coma) to 15 (fully alert).
Measured: 0. postoperative day
Hypoxia
Will be assessed using oxygen saturation levels (SpO₂). Mild hypoxia: SpO₂ 90-94% Moderate hypoxia:r SpO₂ 75-89% Severe hypoxia: SpO₂ <75%
Measured: 0. postoperative day
Lactic acidosis
Lactic acidosis is a condition characterized by the accumulation of lactic acid in the bloodstream, leading to a decrease in blood pH. It can result from tissue hypoxia, impaired metabolism, or certain medical conditions.
Lactic acidosis is generally defined by a serum lactate concentration above 4 mmol/L. Mild elevations in lactate (hyperlactatemia) occur at levels above 2 mmol/L, but true lactic acidosis is diagnosed when lactate levels exceed 4 mmol/L
Measured: 0. postoperative day
Syncope
Syncope is a temporary loss of consciousness due to a sudden decrease in blood flow to the brain. It typically has a rapid onset, short duration, and spontaneous recovery
Measured: 0. postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Jun 2025
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension During SurgeryStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tomas Bata Hospital, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klára Nekvindová, Tomas Bata Hospital, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022210
- Sponsor's protocol ID
- 2025-12
- Status last verified
- Jun 2025
- First submitted
- 22 May 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypotension in the Post-anesthesia Care Unit (PACU).
- ClinicalTrials.gov ID
- NCT07022210
- Acronym / sponsor ID
- 2025-12
- Conditions
- Hypotension During Surgery, Surgery-Complications
- Keywords
- hypotension, post-anesthesia care unit, surgery, adult
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tomas Bata Hospital, Czech RepublicUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 15 Jun 2025 (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 perioperative period poses a heightened risk of complications for patients, including hypotension. While the issue of intraoperative hypotension is well-documented in medical literature, the occurrence and causes of hypotension in the post-anesthesia care unit often receive less attention. This phase of postoperative care, however, is vital for ensuring patient stability and preventing severe consequences. Failure to identify and manage a drop in blood pressure can lead to hypoperfusion of critical organs, increasing the risk of morbidity and mortality. The aim of this study is to examine the frequency of hypotension in the post-anesthesia care unit-defined as systolic blood pressure <90 mmHg or a drop of more than 20% from baseline-and to identify factors contributing to its development.
Detailed description
The perioperative period is a critical time for patients, marked by an increased risk of various complications, including hypotension. While intraoperative hypotension is extensively studied in medical literature, the occurrence and underlying causes of hypotension in the post-anesthesia care unit (PACU) often remain overlooked. This phase of postoperative care is essential for stabilizing the patient and preventing severe outcomes. A failure to identify and adequately address a drop in blood pressure during this time can result in hypoperfusion of vital organs, increasing the likelihood of morbidity and mortality.
Hypotension in the PACU is defined as a systolic blood pressure below 90 mmHg or a decrease exceeding 20% compared to the patient's baseline measurements. The aim of this research is to explore the prevalence of hypotension in the PACU and to analyze the factors contributing to its occurrence. By improving the understanding of this issue, the study seeks to enhance patient outcomes through timely identification and management of hypotension in this crucial phase of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients meeting the inclusion criteria, aged 18 to 105 years, with an indicated hospitalization at a diagnostic-therapeutic unit (DTU).
Key inclusion criteria (4 listed)
- patients over 18 years old
- patients undergoing a procedure under general anesthesia
- patients who have consented to data processing
- postoperative stay in PACU
Key exclusion criteria (6 listed)
- patients younger than 18 years old.
- patients transferred directly to the ICU/Anesthesiology and Resuscitation Department after surgery without staying in the recovery room.
- patients with incomplete medical documentation or missing blood pressure values in the recovery room.
- patients with a pre-existing diagnosis of resistant hypotension or unstable hemodynamics before surgery
- patients with a history of long-term use of anxiolytics, antipsychotics, or other psychotropic medications that may affect cognitive function, emotional state, or predictive outcomes
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
Incidence of hypotension in the post-anesthesia care unit (PACU).
Time frame: 0. postoperative day
Hypotension is defined as systolic blood pressure <90 mmHg or a decrease of more than 20% from baseline values.
18 secondary outcomes
Duration of the operation
Time frame: 0. postoperative day
ASA classification (American Society of Anesthesiologists classification).
Time frame: 0. postoperative day
Type of anesthesia.
Time frame: 0. postoperative day
Blood loss during the operation
Time frame: 0. postoperative day
Fluid balance during the surgery
Time frame: 0. postoperative day
Surgical specialty
Time frame: 0. postoperative day
Fluid administration in the recovery room.
Time frame: 0. postoperative day
Administration of vasopressors.
Time frame: 0. postoperative day
Blood pressure monitoring.
Time frame: 0. postoperative day
Heart rate monitoring.
Time frame: 0. postoperative day
Patient repositioning
Time frame: 0. postoperative day
Transfer of the patient to the ICU due to hemodynamic instability
Time frame: 0. postoperative day
Postoperative nausea and vomiting
Time frame: 0. postoperative day
Impaired diuresis (oliguria, anuria)
Time frame: 0. postoperative day
Impaired consciousness - GCS
Time frame: 0. postoperative day
Hypoxia
Time frame: 0. postoperative day
Lactic acidosis
Time frame: 0. postoperative day
Syncope
Time frame: 0. postoperative day
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
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 Hypotension During Surgery and Surgery-Complications, run by Tomas Bata Hospital, Czech Republic 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 4 inclusion and 6 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 10 Jul 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 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 Klára Nekvindová, M.D., P.h.D. (+420 577 551 111, nekvindova.klara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension in the post-anesthesia care unit (PACU). (time frame: 0. postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.