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NCT Number: NCT05671783

Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.

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Key information

Conditions

Post-Induction Hypotension Cardiovascular Diseases Hypotension Intraoperative Hypotension Post Anesthesia Recovery Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acibadem University

Istanbul, 34662, Turkey (Türkiye)

About this study

Background The underlying causative mechanism that leads to intraoperative hypotension (IOH) may vary depending on the stage of anesthesia and surgery, which determines different IOH types. Naturally, the incidence and severity of IOH types will differ, as will the incidence and severity of postoperative complications.

Methods The investigators conducted a data-based observational study that included 4776 patients. Post-induction hypotension (pIOH) is defined as a decrease during the first 20 min after anesthesia induction and maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH.

Who can participate

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

Inclusion criteria

  • 18 years and older
  • Underwent elective surgery
  • Received general anesthesia
  • Planned overnight stay in the hospital after surgery

Exclusion criteria

  • Under 18 years of age
  • Cardiac surgery
  • Transplant surgery
  • Preoperatively receiving vasoactive drugs
  • Patients with mechanical circulatory support
  • Pediatric surgery
  • Patients from ICU
  • Patients with scheduled postoperative ICU admissions

Treatment and study plan

Hemodynamic observation of the patients.

Other

For the purposes of this study, we defined intraoperative hypotension as a decrease in mean blood pressure of 30% from baseline for a minimum of 5 minutes, including induction and maintenance of anesthesia. The measuring blood pressure method (noninvasive or invasive) depended on the surgical intervention's invasiveness and the patient's cardiac performance.

As soon as the patients entered the PACU, the responsible nurses started the standard monitoring. Anesthesiologists constantly oversee all actions based on the patient's condition. Clinical observation for respiratory and gastrointestinal problems and all disorders were monitored. When in room air SO2 was <94, we started oxygen treatment with a 4 liter/minute nasal cannula, and in cases of nausea antiemetic was administered. The Modified Aldrete Score was used to discharge the patent.

Other names: Postoperative clinical observation

Primary outcomes

  1. Effect of IOH types on PACU recovery (Duration)

    Time frame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).

    The underlying causative mechanism that leads to IOH may vary depending on the stage of anesthesia and surgery, which determines different IOH types; therefore recovery after them will differ.

    care unit (PACU) recovery, especially duration and complications in the PACU.

Secondary outcomes

  1. PACU recovery

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Compare the effect of intraoperative hypotension types on PACU recovery to the effect of other factors influencing PACU recovery.

Other outcomes

  1. Effect of IOH types on PACU duration

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Different IOH types may have a different impact on the PACU duration.

  2. Effect of IOH types on PACU complications

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Different IOH types have a different impact on the PACU's complication rate.

  3. Intraoperative hypotension

    Time frame: From the preoperative first monitorization of the patient in the operating room until extubation and transfer to the PACU (0-480 minutes).

    Decrease in mean blood pressure of 30% from baseline for a minimum of 5 minutes, including induction and maintenance of anesthesia.

  4. pIOH

    Time frame: From the preoperative first monitorization of the patient in the operating room to the 20th minute after anesthesia induction.

    Decrease in mean blood pressure of 30% from baseline during the first 20 min after anesthesia induction.

  5. mIOH

    Time frame: From the 20th minute after anesthesia induction until extubation and transfer to the PACU (between 20- 480 minutes).

    Decrease of blood pressure 20th min after induction, with or without pIOH.

  6. PACU complications: desaturation

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Postoperative SpO2<%90

  7. PACU complications: Arrhythmia

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Irregular heartbeat

  8. PACU complications: Bradycardia

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Postoperative heart rate < 40 min

  9. PACU complications: Tachycardia

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Postoperative heart rate >100 min >100 min-1 Heart rate >100 min-1

  10. PACU complications: Gastrointestinal complications

    Time frame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

    Include nausea and vomiting

  11. Unplanned ICU admission

    Time frame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).

    When ICU bed reservation is not considered in the preoperative period.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Different Types of Intraoperative Hypotension and Their Association With Post-anesthesia Care Unit Recovery

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 5, 2023
Registry last updated
Jan 20, 2023

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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