The Association Between Intraoperative Hypotension and Perioperative Stroke

• Conditions: Intraoperative Hypotension; Perioperative Complication
• Interventions: Behavioral: Patiens with intraoperative hypotension

• Registration Number: NCT04117867
• Lead Sponsor: Qianfoshan Hospital

Brief 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.

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 Timeline

• Study First Submitted: 2019-09-27
• Study First Submitted QC: 2019-10-03
• Study First Posted: 2019-10-07
• Study Start: 2019-12-30
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04
• Primary Completion: 2021-11-01
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraoperative hypotension	Patiens with intraoperative hypotension	-

Primary Outcome Measures

Name	Time	Method
Incidence of perioperative stroke	Within 30 days after surgery	Perioperative stroke diagnosed with CT or MRI examination, symptoms and signs

Secondary Outcome Measures

Name	Time	Method
Rate of death	Within 30 days after surgery	Death from any cause
Expense of Healthe care and social service	Through study completion, an average of 14 days	The expense of Healthe care and social service that the patients spent in hospital

Trial Locations

Locations (1)

The First affiliated hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China