AzTrials
AzTrials

Anesthesia Recovery PeriodsNCT06217341

Bispectral Index and Emergence Agitation in Spinal Surgeries

An observational study of Anesthesia Recovery Periods and Anesthesia Complication, run by Bozok University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
In the study, bispectral index monitoring and follow-up will be applied to both groups.
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
29 Dec 2023to 29 Apr 2024
How long will I take part?
1 Day
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Ahmet YUKSEK, Md contact

05326580351

mdayuksek@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Kocaeli City Hospital

    Kocaeli, 41010

    Ahmet YUKSEK, 05326580351, mdayuksek@hotmail.com

    mdayuksek@hotmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
In the study, bispectral index monitoring and follow-up will be applied to both groups.
Keywords
anesthesia, bispectral index, emergence agitation
Medical subject headings
Emergence Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In the study, bispectral index monitoring and follow-up will be applied to both groups.Other

    Also called Bispectral Index Monitoring

    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.

Study groups in NCT06217341
Study groupRoleWhat they receive
emergence agitation groupPatients in the emergence agitation group are patients who are observed to be agitated during recovery according to the Richmond agitation sedation scale after anesthesia.
Receives: Other: In the study, bispectral index monitoring and follow-up will be applied to both groups.
calm groupThe calm group will consist of patients whose agitation scale is below +2 during recovery.
Receives: Other: In the study, bispectral index monitoring and follow-up will be applied to both groups.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The relationship between BIS-SR values and post-anesthesia recovery (Richmond agitation sedation score) and recovery time

    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.

    Measured: intraoperative period and postoperative first 4 hours

Secondary outcomes (1)
  1. The relationship between Bis values and recovery agitation (Richmond agitation sedation score)

    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.

    Measured: intraoperative period and postoperative first 4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start29 Dec 2023
  3. Primary completion29 Mar 2024 (estimated)
  4. Study completion29 Apr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT06217341
Sponsor's protocol ID
2023-32
Status last verified
Jan 2024
First submitted
2 Jan 2024
Last updated
22 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: In case of appropriate request, anonymous patient results and raw data can be shared with written request and institutional permission.

Publications

  • Cornelius BW, Jacobs TM. Pseudocholinesterase Deficiency Considerations: A Case Study. Anesth Prog. 2020 Sep 1;67(3):177-184. doi: 10.2344/anpr-67-03-16.

    PubMed 32992329
  • Eertmans W, Genbrugge C, Vander Laenen M, Boer W, Mesotten D, Dens J, Jans F, De Deyne C. The prognostic value of bispectral index and suppression ratio monitoring after out-of-hospital cardiac arrest: a prospective observational study. Ann Intensive Care. 2018 Mar 2;8(1):34. doi: 10.1186/s13613-018-0380-z.

    PubMed 29500559
  • Evered LA, Chan MTV, Han R, Chu MHM, Cheng BP, Scott DA, Pryor KO, Sessler DI, Veselis R, Frampton C, Sumner M, Ayeni A, Myles PS, Campbell D, Leslie K, Short TG. Anaesthetic depth and delirium after major surgery: a randomised clinical trial. Br J Anaesth. 2021 Nov;127(5):704-712. doi: 10.1016/j.bja.2021.07.021. Epub 2021 Aug 28.

    PubMed 34465469
  • Riker RR, Fraser GL, Wilkins ML. Comparing the bispectral index and suppression ratio with burst suppression of the electroencephalogram during pentobarbital infusions in adult intensive care patients. Pharmacotherapy. 2003 Sep;23(9):1087-93. doi: 10.1592/phco.23.10.1087.32766.

    PubMed 14524640
  • Kreuer S, Wilhelm W, Grundmann U, Larsen R, Bruhn J. Narcotrend index versus bispectral index as electroencephalogram measures of anesthetic drug effect during propofol anesthesia. Anesth Analg. 2004 Mar;98(3):692-7, table of contents. doi: 10.1213/01.ane.0000103182.78466.ef.

    PubMed 14980921
  • Selig C, Riegger C, Dirks B, Pawlik M, Seyfried T, Klingler W. Bispectral index (BIS) and suppression ratio (SR) as an early predictor of unfavourable neurological outcome after cardiac arrest. Resuscitation. 2014 Feb;85(2):221-6. doi: 10.1016/j.resuscitation.2013.11.008. Epub 2013 Nov 25.

    PubMed 24287327

Questions about this trial

What is this clinical trial studying?

An observational study of Anesthesia Recovery Periods and Anesthesia Complication, run by Bozok University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmet YUKSEK, Md (05326580351, mdayuksek@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06217341, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in