Clinical trial NCT04117867: The Association Between Intraoperative Hypotension and Perioperative Stroke
Official title: The Association Between Intraoperative Hypotension and Perioperative Stroke in General Surgery Patients: a Retrospective, Hospital-based Study in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perioperative Complication
Intraoperative Hypotension
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 70000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of perioperative stroke
timeFrame: Within 24 hours after surgery
measure: Incidence of perioperative stroke
timeFrame: Within 3 days after surgery
measure: Incidence of perioperative stroke
timeFrame: Within 7 days after surgery
measure: Incidence of perioperative stroke
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Rate of death
timeFrame: Within 24 hours after surgery
measure: Rate of death
timeFrame: Within 3 days after surgery
measure: Rate of death
timeFrame: Within 7 days after surgery
measure: Rate of death
timeFrame: Within 30 days after surgery
measure: Expense of Healthe care and social service
timeFrame: Through study completion, an average of 14 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First affiliated hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
name: Yuelan Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: