Changes in Cerebral Oxygenation and Cognitive Functions

Completed

• Conditions: Hypotension; Controlled; Cognitive Dysfunction
• Interventions: Drug: Esmolol; Drug: Nitroglycerin

• Registration Number: NCT04948957
• Lead Sponsor: Zonguldak Bulent Ecevit University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Primary Completion: 2016-01-01
• Study Completion: 2016-08-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-12
• Study First Submitted QC: 2021-06-22
• Last Update Submitted: 2021-06-22
• Study First Posted: 2021-07-02
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
esmolol (Group E)	Esmolol	-
nitroglycerin (Group N)	Nitroglycerin	-

Primary Outcome Measures

Name	Time	Method
effects of controlled hypotension on cerebral oxygen saturation	until end of the surgical procedure.	influence of nitroglycerin and esmolol-induced hypotension on cerebral oxygen saturation by measuring regional cerebral oxygen saturation using Near-Infrared Spectroscopy

Secondary Outcome Measures

Name	Time	Method
effects of controlled hypotension on cognitive function	24 hour before surgery and 24 hour after surgery	influence of nitroglycerin and esmolol-induced hypotension on postoperative cognitive function using mini mental test score

Trial Locations

Locations (1)

Zonguldak Bülent Ecevit University Medicine Faculty; 🇹🇷 Zonguldak, Kozlu, Turkey