Monitoring Hypertensive Patients's Cerebral Oxygen Saturation

Hypertension Clinical Trial

— MHPCOS  

Official title:

Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147275
• Other study ID #: TJH-AD-12888
• Secondary ID: 75888
• Status: Completed
• Phase: N/A
• First received: May 22, 2014
• Last updated: November 10, 2014
• Start date: May 2014
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine whether there is a significant decrease in cerebral oxygen saturation in hypertensive patients undergoing major abdominal surgery and their correlation with standard monitoring parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients have hypertension more than 3 year,whether well-controlled or uncontrolled,

• scheduled for major abdominal surgery for at least 2 h

• under general anesthesia

• American Society of Anesthesiologists(ASA)physical status : II ~ III

• Age > 30

Exclusion Criteria:

• pre-existing cerebral pathology for example episodes of cerebral ischemia or stroke;

• ASA physical status >IV

• hepatic failure

• renal failure

• preoperative Mini-Mental State Examination (MMSE) score less than 24

• a history of cardiovascular surgery or craniotomy

• cardiac failure

• respiratory failure

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Anoxia
• Cerebral Infarction
• Cerebral Ischemia
• Hypertension
• Surgical Complications From General Anesthesia

Locations

Country	Name	City	State
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decreases in cerebral oxygen saturation (rSO2) during the surgery		every 5 minutes throughout the surgery	No
Secondary	Change from baseline in Mini-Mental State Exam (MMSE) perioperative period		Baseline, 4 day after surgery	No