Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

NCT ID: NCT06334939

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-08-30

Brief Summary

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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

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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.

Conditions

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Emergence Agitation Anesthesia Recovery Bispectral Index Monitor

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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EA group

The group that includes patients who develop Emergence agitation after anesthesia and during the recovery period.

Bispectral Index Monitoring

Intervention Type 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.

Non EA Group

The group will include calm patients who do not develop Emergence agitation after anesthesia and during the recovery period.

Bispectral Index Monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ahmet Yuksek

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmet Yuksek

Associate Proffesor, MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmet YUKSEK, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli City Hospital

Locations

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Kocaeli City Hospital

Kocaeli, Izmıt, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 14524640 (View on PubMed)

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.

Reference Type RESULT
PMID: 34465469 (View on PubMed)

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.

Reference Type RESULT
PMID: 29500559 (View on PubMed)

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.

Reference Type RESULT
PMID: 24287327 (View on PubMed)

Lewis 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.

Reference Type RESULT
PMID: 31557307 (View on PubMed)

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.

Reference Type RESULT
PMID: 14980921 (View on PubMed)

Other Identifiers

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KSH.2023-32

Identifier Type: -

Identifier Source: org_study_id

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