Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

October 23, 2024 updated by: Ahmet Yuksek

Bispectral Index, Suppression Rate and Recovery 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Izmıt
      • Kocaeli, Izmıt, Turkey, 41100
        • Kocaeli City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients over the age of 18 who will undergo lumbar spine surgery and will be operated under general anesthesia constitute the study population.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EA group
The group that includes patients who develop Emergence agitation after anesthesia and during the recovery period.
Device: Bispectral Index Monitoring

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.
Non EA Group
The group will include calm patients who do not develop Emergence agitation after anesthesia and during the recovery period.
Device: Bispectral Index Monitoring

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 1 hour postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
First 1 hour postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahmet Yuksek

Investigators

  • Principal Investigator: Ahmet YUKSEK, Md, Kocaeli City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

March 21, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

October 24, 2024

Last Update Submitted That Met QC Criteria

October 23, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSH.2023-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Sharing of data is prohibited without written permission from the institution where the research was conducted.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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