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Completed

NCT Number: NCT06334939

Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

Emergence agitation; generally refers to a situation that may occur after a surgical intervention or anesthesia. This situation describes the irritability and agitation of the patient during the recovery process and the period of recovery from anesthesia. Recovery agitation may occur when the patient begins to recover and is usually a short-term condition. It resolves spontaneously. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient's condition and relaxation. Rapid recovery from anesthesia in the clinic is also a risk factor for agitation.

When the literature is examined, there are not enough studies on Bis suppression ratio and its relationship with recovery agitation is not yet known enough. For this purpose, our study aimed to question this relationship.

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Key information

Conditions

Emergence Agitation Anesthesia Recovery Bispectral Index Monitor Confusion Delirium Emergence Delirium Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

About this study

There are not enough studies on BIS suppression ratio, and its relationship with recovery agitation is not yet well known. For this purpose, our study aimed to question this relationship.

For this purpose, patients' post-anesthesia recovery scores and perioperative BIS and BIS suppression rates will be compared.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with ASA score 1,2,3
  • Patients to be extubated in the postoperative operating room
  • Patients without known vascular diseases will be included.

Exclusion criteria

  • Intraoperative surgery or aesthesia complication developments
  • Those who need postoperative intensive care
  • Patients who are not planned to be extubated in the operating room

Treatment and study plan

Bispectral Index Monitoring

Device

Study patients will undergo perioperative bispectral index and BIS suppression ratio (SR) monitoring under anesthesia. The lowest BIS and BIS SR values and the values taken at 10-minute intervals will be recorded throughout the case.

The Richmond agitation scale will be calculated in the recovery room after anesthesia.

Primary outcomes

  1. Relationship between BIS SR value and Emergence Agitation

    Time frame: First 1 hour postoperative

    It will be examined whether there is a significant relationship between the maximum BIS SR value and postoperative recovery agitation.

Secondary outcomes

  1. Relationship between average and lowest BIS values and Emergence agitation

    Time frame: First 1 hour postoperative

    The relationship between mean and lowest BIS values and Emergence agitation will be examined postoperatively.

Sponsors and collaborators

Lead sponsor

Ahmet Yuksek

Other Gov

Registry information

Official study title

Bispectral Index, Suppression Rate and Recovery Agitation in Spine Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Oct 24, 2024

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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