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NCT04948957 Clinical Trial

Changes in Cerebral Oxygenation and Cognitive Functions

Cognitive Dysfunction Clinical Trial

Official title:
Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04948957
Other study ID # 2013-81-03/09
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2014
Est. completion date August 1, 2016

Study information
Verified date June 2021
Source Zonguldak Bulent Ecevit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The present study aimed to assess the influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by using near-infrared spectroscopy and postoperative cognitive function in patients undergoing nasal surgery.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date August 1, 2016
Est. primary completion date January 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - written informed consent - patients with ASA physical status of I-II - aged 18-65 years Exclusion Criteria: - Age under 18 or above 65 - ASA > II - coagulation disorders - history of cardiovascular and cerebrovascular disease - poor Blood Pressure control - anemia, pregnancy, addiction to opioids - body mass index (BMI) > 35 - intraoperative systolic BP < 65 mmHg - surgical duration less than 30 minutes or more than 160 minutes - need for an intraoperative sympathomimetic drug and the use of other hypotensive drugs - preoperative Mini-Mental State Examination (MMSE) score of 23 or less.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Esmolol

• Nitroglycerin

Locations
Country Name City State
Turkey Zonguldak Bülent Ecevit University Medicine Faculty Zonguldak Kozlu

Sponsors (1)
Lead Sponsor Collaborator
Zonguldak Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary effects of controlled hypotension on cerebral oxygen saturation influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy until end of the surgical procedure.
Secondary effects of controlled hypotension on cognitive function influence of nitroglycerin and esmolol-induced hypotension on postoperative cognitive function using mini mental test score 24 hour before surgery and 24 hour after surgery
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