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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Hypotension

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