Bispectral Index and Emergence Agitation in Spinal Surgeries

January 11, 2024 updated by: Ahmet YUKSEK, Bozok University
Recovery and emergence agitation is a problem that occurs after anesthesia and requires urgent intervention. The effects of changes in EEG waves during anesthesia or undesirable deep periods in Bispectral index (BIS) monitoring on recovery agitation are the subject of this research.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Many strategies have been developed to monitor perioperative anesthesia depth. Bispectral index (BIS) is a monitor that analyzes electroencephalogram (EEG) data and produces a numerical value. This value indicates the patient's level of consciousness and helps evaluate the depth of anesthesia. BIS is a routinely used monitor that continuously monitors the patient's state of consciousness during anesthesia. In this way, the depth of anesthesia can be controlled more precisely (1). When the level of consciousness is deep, the BIS value decreases and increases as the surface is approached. With this feature, it ensures that the patient's depth of anesthesia is kept at an optimal level and adjusted when necessary. This may help minimize anesthesia-related complications(2). BIS alone may not be sufficient to evaluate the depth of anesthesia. It should be used in conjunction with other clinical findings and monitors. Nowadays, anesthesia depth monitoring is a widely used method and is performed routinely in our clinic.

Many strategies have been developed to monitor perioperative anesthesia depth. BIS is a monitor that analyzes electroencephalogram (EEG) data and produces a numerical value. This value indicates the patient's level of consciousness and helps evaluate the depth of anesthesia. BIS is a routinely used monitor that continuously monitors the patient's state of consciousness during anesthesia. In this way, the depth of anesthesia can be controlled more precisely (1). When the level of consciousness is deep, the BIS value decreases and increases as the surface is approached. With this feature, it ensures that the patient's depth of anesthesia is kept at an optimal level and adjusted when necessary. This may help minimize anesthesia-related complications(2). BIS alone may not be sufficient to evaluate the depth of anesthesia. It should be used in conjunction with other clinical findings and monitors. Nowadays, anesthesia depth monitoring is a widely used method and is performed routinely in our clinic.

BIS (Bisspectral Index) Suppression Ratio is a value that measures the suppression rate of brain activity during anesthesia (3). This rate is calculated by analyzing EEG (Electroencephalogram) signals. This ratio indicates significant decreases in brain activity and increases as anesthesia deepens (4). Suppression is often desired in cases of deep anesthesia, especially during surgical intervention. However, an excessively high suppression rate can lead to delayed recovery times. The use of BIS Suppression Ratio in anesthesia management can help to more precisely control the patient's arousal process and the depth of general anesthesia. This value provides the anesthesia team with a guide to optimize the patient's state of consciousness and minimize complications that may occur during anesthesia. However, it is important that BIS Suppression Ratio should not be evaluated alone and should be used in conjunction with other clinical information(5). Each patient's response may be different, and therefore the anesthesia team must manage the depth of anesthesia by considering multiple factors. It has been shown in the literature that BIS Suppression Ratio (SR) values >40 have a similar effect to low BIS values. However, the undesirable Suppression Ratio in terms of number and duration is not fully known (6).

"Recovery agitation" generally refers to a situation that may occur after a surgical intervention or anesthesia. This condition describes the restlessness and agitation (symptoms such as restlessness, tension, insomnia) that the patient shows during the awakening process and during the recovery period from anesthesia. Recovery agitation sometimes occurs when the patient tries to wake up. It may occur when it starts and is usually a short-term condition that resolves on its own. However, in some cases, this agitation may be more pronounced and disturbing. This may affect the patient's condition and relaxation. The severity of the agitation may vary from person to person. Rapid recovery from anesthesia in the clinic is also a risk of agitation. Riker Sedation-Agitation Scale and Richmond Agitation-Sedation scale are the most frequently used methods to measure recovery agitation (7).

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

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

Study Contact

Study Locations

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

Non-Probability Sample

Study Population

The current research was designed as a prospective observational study. Routine anesthesia procedures will be applied to patients who will undergo lumbar disc herniation surgery and who have agreed to participate in the study, and the routinely recorded recovery scale will be recorded for the study.

Description

Inclusion Criteria:

  • 1. Patients who will undergo lumbar disc herniation surgery in Kocaeli city hospital operating rooms will be included in our study after ethics committee approval.

    2. Patients over the age of 18 will be included in the study.

    3. Patients with an ASA score of 1-2 and without neurological disease will be included.

    4.Patients without known vascular diseases will be included.

    5. Study patients will receive routine anesthesia premedication and routine analgesics, and patients with different procedures will not be included in the study.

Exclusion Criteria:

  • 1. Patients who do not want to participate in the study will not be included.

    2. Patients with intraoperative profound hypotension (mean arterial pressure <50) will be excluded.

    3. Those who develop intraoperative hypothermia or other anesthesia complications will be removed.

    4. Patients who will not be extubated postoperatively will be excluded from the study.

    5. Those with neurological diseases or using psychiatric medications will also be excluded from the study.

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
emergence agitation group
Patients in the emergence agitation group are patients who are observed to be agitated during recovery according to the Richmond agitation sedation scale after anesthesia.
Other: In the study, bispectral index monitoring and follow-up will be applied to both groups.
Perioperative Bispectral Index Monitoring (BIS) monitor and Bispectral Index suppression Rate (BIS-SR) monitoring will be applied. The duration and magnitude of BIS-SR values will be examined together with BIS values in terms of recovery agitation.
Other Names:
  • Bispectral Index Monitoring
calm group
The calm group will consist of patients whose agitation scale is below +2 during recovery.
Other: In the study, bispectral index monitoring and follow-up will be applied to both groups.
Perioperative Bispectral Index Monitoring (BIS) monitor and Bispectral Index suppression Rate (BIS-SR) monitoring will be applied. The duration and magnitude of BIS-SR values will be examined together with BIS values in terms of recovery agitation.
Other Names:
  • Bispectral Index Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between BIS-SR values and post-anesthesia recovery (Richmond agitation sedation score) and recovery time
Time Frame: intraoperative period and postoperative first 4 hours
The relationship between the maximum BIS-SR value or the time of SR>10 points and recovery times and recovery agitation (Richmond agitation sedation score) will be investigated.
intraoperative period and postoperative first 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between Bis values and recovery agitation (Richmond agitation sedation score)
Time Frame: intraoperative period and postoperative first 4 hours
A relationship between Bis values and recovery agitation (Richmond agitation sedation score) will be investigated. Possible changes in SR values will also be observed when BIS is in the range of 40-60 percent.
intraoperative period and postoperative first 4 hours

Collaborators and Investigators

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

Sponsor

Bozok University

Investigators

  • Study Chair: 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)

December 29, 2023

Primary Completion (Estimated)

March 29, 2024

Study Completion (Estimated)

April 29, 2024

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-32

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In case of appropriate request, anonymous patient results and raw data can be shared with written request and institutional permission.

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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