Changes in Cerebral Oxygenation and Cognitive Functions

NCT ID: NCT04948957

Last Updated: 2021-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-01

Study Completion Date

2016-08-01

Brief Summary

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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

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Conditions

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Hypotension; Controlled Cognitive Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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esmolol (Group E)

Esmolol

Intervention Type DRUG

nitroglycerin (Group N)

Nitroglycerin

Intervention Type DRUG

Interventions

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Esmolol

Intervention Type DRUG

Nitroglycerin

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zonguldak Bulent Ecevit University

OTHER

Sponsor Role lead

Responsible Party

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Bengü Gülhan Aydin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zonguldak Bülent Ecevit University Medicine Faculty

Zonguldak, Kozlu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013-81-03/09

Identifier Type: -

Identifier Source: org_study_id

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