The Association Between Intraoperative Hypotension and Perioperative Stroke

The Association Between Intraoperative Hypotension and Perioperative Stroke in General Surgery Patients: a Retrospective, Hospital-based Study in China

The aim of this study is to investigate the association between the severity and duration of intraoperative hypotension and the incidence of perioperative stroke after non-cardiac and non-neurologic surgeries.The secondary aim of this study is to confirm the potential risk factors of the perioperative stroke.

Study Overview

• Status: Unknown
• Conditions: Intraoperative Hypotension; Perioperative Complication
• Intervention / Treatment: Behavioral: Patiens with intraoperative hypotension

Detailed Description

Optimized intraoperative management may play an important role in perioperative stroke prevention. Maintaining blood pressure near preoperative baseline values may help decrease the incidence of stroke, however the related evidence is limited.Therefore, this study is to investigate the association between intraoperative hemodynamic variable and the risk of perioperative stroke after non-cardiac and non-neurologic surgeries. The secondary aim of this study is to establish the potential risk factors of the perioperative stroke.

• Study Type: Observational
• Enrollment (Anticipated): 70000

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University
      • Contact: Lili Cao, PH.D
      • Principal Investigator: Yuelan Wang, PH.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent surgical procedures under anesthesia at Qianfoshan Hospital, First Hospital affiliated to Shandong First Medical University during the period from January, 2013, to October, 2019, will be included.

Description

Inclusion Criteria:

1. Patients underwent surgeries in First hospital affiliated to Shandong First Medical University from January 2013 to October 2019
2. Age>18 or older

Exclusion Criteria:

1. Patients received local infiltration anesthesia
2. Patients underwent total intravenous anesthsia without tracheal intubation or Laryngeal Mask Airway insertion
3. Major vascular operation
4. Neurologic surgery
5. Cariac surgery
6. Intraoperative blood pressure measurements or postoperative neuroimagings measurements are not available
7. History of severe neurological or psychiatric disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intraoperative hypotension

Behavioral: Patiens with intraoperative hypotension; In this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 24 hours after surgery
Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 3 days after surgery
Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 7 days after surgery
Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of death	Death from any cause	Within 24 hours after surgery
Rate of death	Death from any cause	Within 3 days after surgery
Rate of death	Death from any cause	Within 7 days after surgery
Rate of death	Death from any cause	Within 30 days after surgery
Expense of Healthe care and social service	The expense of Healthe care and social service that the patients spent in hospital	Through study completion, an average of 14 days

Collaborators and Investigators

• Sponsor: Qianfoshan Hospital
• Investigators: Principal Investigator: Yuelan Wang, Doctor, Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2019
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: September 27, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: IOHPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

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