Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

NCT05671783 | Completed

• 1 other identifier: 2022-08/10
• Study Type: observational
• Target: 4,776
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-induction Hypotension; Post Anesthesia Recovery; Hypotension; Intraoperative Hypotension

Keywords

Complication; Intraoperative Hypotension; PACU outcomes; PACU recovery; Hypotension

Outcome Measures

Primary Outcomes (1)

• Effect of IOH types on PACU recovery (Duration)

  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.

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

Secondary Outcomes (1)

• PACU recovery

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

Other Outcomes (11)

• Effect of IOH types on PACU duration

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

• Effect of IOH types on PACU complications

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

• Intraoperative hypotension

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

Study Arms (3)

Post-induction hypotension

Post-induction hypotension (pIOH) is a decrease during the first 20 min after anesthesia induction

Other: Hemodynamic observation of the patients.

Maintenance intraoperative hypotension

maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH

Other: Hemodynamic observation of the patients.

Normotensive patients

Patients with normotension during surgery.

Other: Hemodynamic observation of the patients.

Interventions

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.

Also known as: Postoperative clinical observation

Maintenance intraoperative hypotension; Normotensive patients; Post-induction hypotension

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem University

Istanbul, 34662, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 17667564 BACKGROUND

• 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.

  PMID: 28974066 BACKGROUND

• 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.

  PMID: 33177322 BACKGROUND

• 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.

  PMID: 9728843 BACKGROUND

• 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.

  PMID: 34859868 BACKGROUND

• 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.

  PMID: 30027443 BACKGROUND

• Dogan L, Yildirim SA, Sarikaya T, Ulugol H, Gucyetmez B, Toraman F. Different Types of Intraoperative Hypotension and their Association with Post-Anesthesia Care Unit Recovery. Glob Heart. 2023 Aug 11;18(1):44. doi: 10.5334/gh.1257. eCollection 2023.

  PMID: 37577293 DERIVED

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lerzan Dogan, MD

  Acibadem University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2022
• First Posted: January 5, 2023
• Study Start: May 6, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 15, 2022
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year
• Access Criteria: valid reason

Locations

TU (1)