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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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.

Klára Nekvindová, M.D., P.h.D. contact

+420 577 551 111

nekvindova.klara@gmail.com

Czechia1 site, 1 recruiting
  • Tomas Bata regional Hospital

    Zlín, 76001

    Recruiting

Other trials in Czechia

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.

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.

  1. 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)
  1. 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

  2. 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

  3. Type of anesthesia.

    The type of anesthesia used: general, regional, and/or peripheral nerve block.

    Measured: 0. postoperative day

  4. Blood loss during the operation

    Blood loss during the surgical procedure, as documented in the surgical protocol.

    Measured: 0. postoperative day

  5. Fluid balance during the surgery

    Fluid intake and output during surgery, measured in milliliters.

    Measured: 0. postoperative day

  6. Surgical specialty

    Surgical specialties: neurosurgery, urology, gynecology, abdominal surgery, orthopedics

    Measured: 0. postoperative day

  7. Fluid administration in the recovery room.

    Administration of a crystalloid or colloid bolus to augment intravascular volume.

    Measured: 0. postoperative day

  8. 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

  9. Blood pressure monitoring.

    Repeated blood pressure measurement every 5 minutes.

    Measured: 0. postoperative day

  10. Heart rate monitoring.

    Continuous heart rate monitoring.

    Measured: 0. postoperative day

  11. 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

  12. 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

  13. Postoperative nausea and vomiting

    Inadequate gastrointestinal perfusion can lead to nausea and vomiting, complicating the patient's recovery.

    Measured: 0. postoperative day

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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.

  1. First posted15 Jun 2025
  2. Study start15 Jun 2025
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2026 (estimated)

Resources

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)
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

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.

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