Clinical trial NCT07022210: Incidence of Hypotension in the Post-anesthesia Care Unit (PACU).
Official title: Incidence of Hypotension in the Post-anesthesia Care Unit (PACU).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypotension During Surgery
Surgery-Complications
Keywords: hypotension
post-anesthesia care unit
surgery
adult
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients meeting the inclusion criteria, aged 18 to 105 years, with an indicated hospitalization at a diagnostic-therapeutic unit (DTU).

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hypotension in the post-anesthesia care unit (PACU).
timeFrame: 0. postoperative day
Secondary outcomes:
measure: Duration of the operation
timeFrame: 0. postoperative day
measure: ASA classification (American Society of Anesthesiologists classification).
timeFrame: 0. postoperative day
measure: Type of anesthesia.
timeFrame: 0. postoperative day
measure: Blood loss during the operation
timeFrame: 0. postoperative day
measure: Fluid balance during the surgery
timeFrame: 0. postoperative day
measure: Surgical specialty
timeFrame: 0. postoperative day
measure: Fluid administration in the recovery room.
timeFrame: 0. postoperative day
measure: Administration of vasopressors.
timeFrame: 0. postoperative day
measure: Blood pressure monitoring.
timeFrame: 0. postoperative day
measure: Heart rate monitoring.
timeFrame: 0. postoperative day
measure: Patient repositioning
timeFrame: 0. postoperative day
measure: Transfer of the patient to the ICU due to hemodynamic instability
timeFrame: 0. postoperative day
measure: Postoperative nausea and vomiting
timeFrame: 0. postoperative day
measure: Impaired diuresis (oliguria, anuria)
timeFrame: 0. postoperative day
measure: Impaired consciousness - GCS
timeFrame: 0. postoperative day
measure: Hypoxia
timeFrame: 0. postoperative day
measure: Lactic acidosis
timeFrame: 0. postoperative day
measure: Syncope
timeFrame: 0. postoperative day
Other outcomes:
Locations:
Study officials:
References: