Clinical trial NCT05671783: Intraoperative Hypotension and Post-anesthesia Care Unit Recovery
Official title: Different Types of Intraoperative Hypotension and Their Association With Post-anesthesia Care Unit Recovery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-induction Hypotension
Post Anesthesia Recovery
Hypotension
Intraoperative Hypotension
Keywords: Complication
Intraoperative Hypotension
PACU outcomes
PACU recovery
Hypotension
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 4776
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We conducted a data-based observational study. Only routinely documented patient data was considered in the recent study. All patients' preoperative and postoperative recovery room data is recorded in a virtual environment. Data describing consecutive patients were collected until the patient was discharged to a ward. Data included demographics, comorbidities, perioperative hemodynamic parameters, duration of PACU, complications in PACU, and non-planned intensive care admission.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Effect of IOH types on PACU recovery (Duration)
timeFrame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).
Secondary outcomes:
measure: PACU recovery
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Other outcomes:
measure: Effect of IOH types on PACU duration
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: Effect of IOH types on PACU complications
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: Intraoperative hypotension
timeFrame: From the preoperative first monitorization of the patient in the operating room until extubation and transfer to the PACU (0-480 minutes).
measure: pIOH
timeFrame: From the preoperative first monitorization of the patient in the operating room to the 20th minute after anesthesia induction.
measure: mIOH
timeFrame: From the 20th minute after anesthesia induction until extubation and transfer to the PACU (between 20- 480 minutes).
measure: PACU complications: desaturation
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: PACU complications: Arrhythmia
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: PACU complications: Bradycardia
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: PACU complications: Tachycardia
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: PACU complications: Gastrointestinal complications
timeFrame: Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
measure: Unplanned ICU admission
timeFrame: From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Acibadem University
name: Lerzan Dogan, MD
role: STUDY_CHAIR
References:
citation: Bijker JB, van Klei WA, Kappen TH, van Wolfswinkel L, Moons KG, Kalkman CJ. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology. 2007 Aug;107(2):213-20. doi: 10.1097/01.anes.0000270724.40897.8e.
citation: Sudfeld S, Brechnitz S, Wagner JY, Reese PC, Pinnschmidt HO, Reuter DA, Saugel B. Post-induction hypotension and early intraoperative hypotension associated with general anaesthesia. Br J Anaesth. 2017 Jul 1;119(1):57-64. doi: 10.1093/bja/aex127.
citation: Gregory A, Stapelfeldt WH, Khanna AK, Smischney NJ, Boero IJ, Chen Q, Stevens M, Shaw AD. Intraoperative Hypotension Is Associated With Adverse Clinical Outcomes After Noncardiac Surgery. Anesth Analg. 2021 Jun 1;132(6):1654-1665. doi: 10.1213/ANE.0000000000005250.
citation: Waddle JP, Evers AS, Piccirillo JF. Postanesthesia care unit length of stay: quantifying and assessing dependent factors. Anesth Analg. 1998 Sep;87(3):628-33. doi: 10.1097/00000539-199809000-00026.
citation: Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.
citation: Jor O, Maca J, Koutna J, Gemrotova M, Vymazal T, Litschmannova M, Sevcik P, Reimer P, Mikulova V, Trlicova M, Cerny V. Hypotension after induction of general anesthesia: occurrence, risk factors, and therapy. A prospective multicentre observational study. J Anesth. 2018 Oct;32(5):673-680. doi: 10.1007/s00540-018-2532-6. Epub 2018 Jul 19.