Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

Different Types of Intraoperative Hypotension and Their Association With 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.

Study Overview

• Status: Completed
• Conditions: Hypotension; Intraoperative Hypotension; Post-induction Hypotension; Post Anesthesia Recovery
• Intervention / Treatment: Other: Hemodynamic observation of the patients.

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.

• Study Type: Observational
• Enrollment (Actual): 4776

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34662
    • Acibadem University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Post-induction hypotension; Post-induction hypotension (pIOH) is a decrease during the first 20 min after anesthesia induction	Other: Hemodynamic observation of the patients.; 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
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.; 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
Normotensive patients; Patients with normotension during surgery.	Other: Hemodynamic observation of the patients.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PACU recovery	Compare the effect of intraoperative hypotension types on PACU recovery to the effect of other factors influencing PACU recovery.	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of IOH types on PACU duration	Different IOH types may have a different impact on the PACU duration.	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Effect of IOH types on PACU complications	Different IOH types have a different impact on the PACU's complication rate.	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Intraoperative hypotension	Decrease in mean blood pressure of 30% from baseline for a minimum of 5 minutes, including induction and maintenance of anesthesia.	From the preoperative first monitorization of the patient in the operating room until extubation and transfer to the PACU (0-480 minutes).
pIOH	Decrease in mean blood pressure of 30% from baseline during the first 20 min after anesthesia induction.	From the preoperative first monitorization of the patient in the operating room to the 20th minute after anesthesia induction.
mIOH	Decrease of blood pressure 20th min after induction, with or without pIOH.	From the 20th minute after anesthesia induction until extubation and transfer to the PACU (between 20- 480 minutes).
PACU complications: desaturation	Postoperative SpO2<%90	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
PACU complications: Arrhythmia	Irregular heartbeat	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
PACU complications: Bradycardia	Postoperative heart rate < 40 min	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
PACU complications: Tachycardia	Postoperative heart rate >100 min >100 min-1 Heart rate >100 min-1	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
PACU complications: Gastrointestinal complications	Include nausea and vomiting	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Unplanned ICU admission	When ICU bed reservation is not considered in the preoperative period.	From the preoperative first monitorization of the patient in the operating room until until discharege from the PACU (0-720 minutes).

Collaborators and Investigators

• Sponsor: Acibadem University
• Investigators: Study Chair: Lerzan Dogan, MD, Acibadem University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2022
• Primary Completion (Actual): November 30, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: December 21, 2022
• First Posted (Actual): January 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Hypotension; Complication; Intraoperative Hypotension; PACU outcomes; PACU recovery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2022-08/10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data on patients is available.
• IPD Sharing Time Frame: 1 year
• IPD Sharing Access Criteria: valid reason
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No