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NCT Number: NCT07022210

Incidence of Hypotension in the Post-anesthesia Care Unit (PACU).

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.

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Key information

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tomas Bata regional Hospital

Zlín, 76001, Czechia

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients over 18 years old
  • patients undergoing a procedure under general anesthesia
  • patients who have consented to data processing
  • postoperative stay in PACU

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of the operation

    Time frame: 0. postoperative day

    Duration of the surgical procedure as a risk factor for the development of postoperative hypotension. The duration will be recorded in minutes.

  2. ASA classification (American Society of Anesthesiologists classification).

    Time frame: 0. postoperative day

    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).

  3. Type of anesthesia.

    Time frame: 0. postoperative day

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

  4. Blood loss during the operation

    Time frame: 0. postoperative day

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

  5. Fluid balance during the surgery

    Time frame: 0. postoperative day

    Fluid intake and output during surgery, measured in milliliters.

  6. Surgical specialty

    Time frame: 0. postoperative day

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

  7. Fluid administration in the recovery room.

    Time frame: 0. postoperative day

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

  8. Administration of vasopressors.

    Time frame: 0. postoperative day

    In cases of severe hypotension, vasopressor administration (e.g., ephedrine, phenylephrine, norepinephrine) may be required to ensure adequate perfusion of vital organs.

  9. Blood pressure monitoring.

    Time frame: 0. postoperative day

    Repeated blood pressure measurement every 5 minutes.

  10. Heart rate monitoring.

    Time frame: 0. postoperative day

    Continuous heart rate monitoring.

  11. Patient repositioning

    Time frame: 0. postoperative day

    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.

  12. Transfer of the patient to the ICU due to hemodynamic instability

    Time frame: 0. postoperative day

    If hypotension does not improve despite repeated therapeutic interventions, escalation of care to the ICU may be necessary.

  13. Postoperative nausea and vomiting

    Time frame: 0. postoperative day

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

  14. Impaired diuresis (oliguria, anuria)

    Time frame: 0. postoperative day

    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.

  15. Impaired consciousness - GCS

    Time frame: 0. postoperative day

    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).

  16. Hypoxia

    Time frame: 0. postoperative day

    Will be assessed using oxygen saturation levels (SpO₂). Mild hypoxia: SpO₂ 90-94% Moderate hypoxia:r SpO₂ 75-89% Severe hypoxia: SpO₂ <75%

  17. Lactic acidosis

    Time frame: 0. postoperative day

    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

  18. Syncope

    Time frame: 0. postoperative day

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Klára Nekvindová, M.D., P.h.D.

CONTACT

[email protected]

+420 577 551 111

Sponsors and collaborators

Lead sponsor

Tomas Bata Hospital, Czech Republic

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 15, 2025
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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