Monitoring Hypertensive Patients's Cerebral Oxygen Saturation (MHPCOS)

November 10, 2014 updated by: Li Hongyi, Huazhong University of Science and Technology

Monitoring Cerebral Oxygen Saturation in Hypertensive Patients Undergoing Major Abdominal Surgery

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

41

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients scheduled for major abdominal surgery such as gastrectomy, colon resection ,liver resection and duodenocephalo-pancreasectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
hypertension disease
patients have hypertension disease, whether well-controlled or uncontrolled, more than 3 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
decreases in cerebral oxygen saturation (rSO2) during the surgery
Time Frame: every 5 minutes throughout the surgery
every 5 minutes throughout the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Mini-Mental State Exam (MMSE) perioperative period
Time Frame: Baseline, 4 day after surgery
Baseline, 4 day after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huazhong University of Science and Technology

Investigators

  • Study Director: Peng Wang, MD PHD, Vice Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 10, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJH-AD-12888
  • 75888 (Other Identifier: Tongji hospital)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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