Changes in Cerebral Oxygenation and Cognitive Functions

Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Dysfunction; Hypotension; Controlled
• Intervention / Treatment: Drug: Nitroglycerin; Drug: Esmolol

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Kozlu
    • Zonguldak, Kozlu, Turkey, 67600
      • Zonguldak Bülent Ecevit University medicine faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- required controlled hypotension scheduled for nasal surgeries

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
esmolol (Group E)	Drug: Esmolol
nitroglycerin (Group N)	Drug: Nitroglycerin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zonguldak Bulent Ecevit University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: June 12, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: cognitive function; cerebral oxygenation; esmolol; nitroglycerine
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Hypotension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Adrenergic beta-1 Receptor Antagonists; Nitroglycerin; Esmolol
• Other Study ID Numbers: 2013-81-03/09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No