Intraoperative Hypotension and Post-anesthesia Care Unit Recovery

Completed

• Conditions: Post Anesthesia Recovery; Post-induction Hypotension; Intraoperative Hypotension; Hypotension
• Interventions: Other: Hemodynamic observation of the patients.

• Registration Number: NCT05671783
• Lead Sponsor: Acibadem University

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.

Study Timeline

• Study Start: 2022-05-06
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-15
• Study First Submitted: 2022-12-21
• Study First Submitted QC: 2022-12-21
• Status Verified: 2023-01
• Study First Posted: 2023-01-05
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4776

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Maintenance intraoperative hypotension	Hemodynamic observation of the patients.	maintenance intraoperative hypotension (mIOH) when there is a decrease of blood pressure 20th min after induction, with or without pIOH
Post-induction hypotension	Hemodynamic observation of the patients.	Post-induction hypotension (pIOH) is a decrease during the first 20 min after anesthesia induction
Normotensive patients	Hemodynamic observation of the patients.	Patients with normotension during surgery.

Primary Outcome Measures

Name	Time	Method
Effect of IOH types on PACU recovery (Duration)	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 Outcome Measures

Name	Time	Method
PACU recovery	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.

Trial Locations

Locations (1)

Acibadem University; 🇹🇷 Istanbul, Turkey