Clinical trial NCT06334939: Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries
Official title: Bispectral Index, Suppression Rate and Recovery Agitation in Spine Surgeries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergence Agitation
Anesthesia Recovery
Bispectral Index Monitor
Keywords: bispectral index
emergence agitation
spine surgery
postoperative recovery
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-28
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

Brief 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. 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\&amp;#39;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\&amp;#39; post-anesthesia recovery scores and perioperative BIS and BIS suppression rates will be compared.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between BIS SR value and Emergence Agitation
timeFrame: First 1 hour postoperative
Secondary outcomes:
measure: Relationship between average and lowest BIS values and Emergence agitation
timeFrame: First 1 hour postoperative
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
state: Izmıt
Study officials:
affiliation: Kocaeli City Hospital
name: Ahmet YUKSEK, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.