Emergence AgitationNCT06334939
Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries
An observational study of Emergence Agitation and Anesthesia Recovery, run by Ahmet Yuksek at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergence Agitation, Anesthesia Recovery, Bispectral Index Monitor
- What is being tested?
- Bispectral Index Monitoring
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 30 Aug 2024
- 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: Patients over the age of 18 who will undergo lumbar spine surgery and will be operated under general anesthesia constitute the study population.
Who may be able to join
- Patients with ASA score 1,2,3
- Patients to be extubated in the postoperative operating room
- Patients without known vascular diseases will be included.
Who cannot join
- Intraoperative surgery or aesthesia complication developments
- Those who need postoperative intensive care
- Patients who are not planned to be extubated in the operating room
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Bispectral Index Monitoring
- Keywords
- bispectral index, emergence agitation, spine surgery, postoperative recovery
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral Index MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| EA group | The group that includes patients who develop Emergence agitation after anesthesia and during the recovery period. Receives: Device: Bispectral Index Monitoring | |
| Non EA Group | The group will include calm patients who do not develop Emergence agitation after anesthesia and during the recovery period. Receives: Device: Bispectral Index Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between BIS SR value and Emergence Agitation
It will be examined whether there is a significant relationship between the maximum BIS SR value and postoperative recovery agitation.
Measured: First 1 hour postoperative
Secondary outcomes (1)
Relationship between average and lowest BIS values and Emergence agitation
The relationship between mean and lowest BIS values and Emergence agitation will be examined postoperatively.
Measured: First 1 hour postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start1 Jan 2024
- Primary completion1 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Emergence AgitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmet Yuksek
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Ahmet Yuksek, Kocaeli City Hospital
- Investigators
- Ahmet YUKSEK, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06334939
- Sponsor's protocol ID
- KSH.2023-32
- Status last verified
- Oct 2024
- First submitted
- 21 Mar 2024
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of data is prohibited without written permission from the institution where the research was conducted.
Publications
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 14524640Evered 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 34465469Eertmans 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 29500559Selig 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 24287327Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.
PubMed 31557307Kreuer 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index, Suppression Rate and Recovery Agitation in Spine Surgeries
- ClinicalTrials.gov ID
- NCT06334939
- Acronym / sponsor ID
- KSH.2023-32
- Keywords
- bispectral index, emergence agitation, spine surgery, postoperative recovery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ahmet YuksekOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 28 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA group | – | Device: Bispectral Index MonitoringThe group that includes patients who develop Emergence agitation after anesthesia and during the recovery period. |
| Non EA Group | – | Device: Bispectral Index MonitoringThe group will include calm patients who do not develop Emergence agitation after anesthesia and during the recovery period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with ASA score 1,2,3
- Patients to be extubated in the postoperative operating room
- Patients without known vascular diseases will be included.
Key exclusion criteria (3 listed)
- Intraoperative surgery or aesthesia complication developments
- Those who need postoperative intensive care
- Patients who are not planned to be extubated in the operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral Index MonitoringStudy 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. | Device | EA group, Non EA Group |
Primary outcome
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.
1 secondary outcome
Relationship between average and lowest BIS values and Emergence agitation
Time frame: First 1 hour postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Results publication: PubMed 14524640Riker 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.
- Results publication: PubMed 34465469Evered 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.
- Results publication: PubMed 29500559Eertmans 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.
- Results publication: PubMed 24287327Selig 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.
- Results publication: PubMed 31557307Lewis SR, Pritchard MW, Fawcett LJ, Punjasawadwong Y. Bispectral index for improving intraoperative awareness and early postoperative recovery in adults. Cochrane Database Syst Rev. 2019 Sep 26;9(9):CD003843. doi: 10.1002/14651858.CD003843.pub4.
- Results publication: PubMed 14980921Kreuer 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.
- Individual participant dataSharing planned: No. Sharing of data is prohibited without written permission from the institution where the research was conducted.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet YUKSEK, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergence Agitation and Anesthesia Recovery, run by Ahmet Yuksek 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between BIS SR value and Emergence Agitation (time frame: First 1 hour postoperative). 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 NCT06334939, 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 24 Oct 2024.