The Association Between Intraoperative Hypotension and Perioperative Stroke

Perioperative Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04117867
• Other study ID #: IOHPS
• Status: Recruiting
• Start date: December 30, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: December 2020
• Source: Qianfoshan Hospital
• Contact: Yuelan Wang, Doctor
• Phone: +86053189268535
• Email: qylvmeng[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70000
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intraoperative Hypotension
• Perioperative Complication

Intervention

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.

Locations

Country	Name	City	State
China	The First affiliated hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qianfoshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 24 hours after surgery
Primary	Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 3 days after surgery
Primary	Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 7 days after surgery
Primary	Incidence of perioperative stroke	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs	Within 30 days after surgery
Secondary	Rate of death	Death from any cause	Within 24 hours after surgery
Secondary	Rate of death	Death from any cause	Within 3 days after surgery
Secondary	Rate of death	Death from any cause	Within 7 days after surgery
Secondary	Rate of death	Death from any cause	Within 30 days after surgery
Secondary	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