NCT07022210

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

June 15, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

July 10, 2025

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

May 22, 2025

Last Update Submit

July 6, 2025

Conditions

Keywords

hypotensionpost-anesthesia care unitsurgeryadult

Outcome Measures

Primary Outcomes (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.

    0. postoperative day

Secondary Outcomes (18)

  • Duration of the operation

    0. postoperative day

  • ASA classification (American Society of Anesthesiologists classification).

    0. postoperative day

  • Type of anesthesia.

    0. postoperative day

  • Blood loss during the operation

    0. postoperative day

  • Fluid balance during the surgery

    0. postoperative day

  • +13 more secondary outcomes

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients meeting the inclusion criteria, aged 18 to 105 years, with an indicated hospitalization at a diagnostic-therapeutic unit (DTU).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tomas Bata regional Hospital

Zlín, 76001, Czechia

RECRUITING

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Klára Nekvindová, M.D., P.h.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Chief for Science, Education, and Research

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 15, 2025

Study Start

June 15, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

July 10, 2025

Record last verified: 2025-06

Locations