Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05671783
• Other study ID #: 2022-08/10
• Status: Completed
• Start date: May 6, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: January 2023
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4776
• Est. completion date: December 15, 2022
• Est. primary completion date: November 30, 2022
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension
• Post-induction Hypotension

Intervention

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.

Locations

Country	Name	City	State
Turkey	Acibadem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).
Other	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).
Other	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).
Other	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.
Other	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).
Other	PACU complications: desaturation	Postoperative SpO2<%90	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Other	PACU complications: Arrhythmia	Irregular heartbeat	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Other	PACU complications: Bradycardia	Postoperative heart rate < 40 min	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Other	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).
Other	PACU complications: Gastrointestinal complications	Include nausea and vomiting	Postoperatively from the patient's arrival to the PACU until discharge (0-240 minutes).
Other	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).
Primary	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	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).