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Completed

NCT Number: NCT04948957

Changes in Cerebral Oxygenation and Cognitive Functions

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.

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Key information

Conditions

Hypotension; Controlled Cardiovascular Diseases Cognition Disorders Cognitive Dysfunction Hypotension Mental Disorders Neurocognitive Disorders Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, 67600, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

esmolol

Drug

Nitroglycerin

Drug

Primary outcomes

  1. effects of controlled hypotension on cerebral oxygen saturation

    Time frame: 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 outcomes

  1. effects of controlled hypotension on cognitive function

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

Changes in Cerebral Oxygenation and Cognitive Functions During Controlled Hypotension

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 2, 2021
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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