Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

NCT06334939 | Completed

• 1 other identifier: KSH.2023-32
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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\'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.

Conditions

Emergence Agitation; Anesthesia Recovery; Bispectral Index Monitor

Keywords

bispectral index; emergence agitation; spine surgery; postoperative recovery

Outcome Measures

Primary Outcomes (1)

• 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.

  First 1 hour postoperative

Secondary Outcomes (1)

• Relationship between average and lowest BIS values and Emergence agitation

  First 1 hour postoperative

Study Arms (2)

EA group

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

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.

Device: Bispectral Index Monitoring

Interventions

Bispectral Index Monitoring 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.

EA group; Non EA Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with ASA score 1,2,3
• Patients to be extubated in the postoperative operating room
• Patients without known vascular diseases will be included.

You may not qualify if:

• Intraoperative surgery or aesthesia complication developments
• Those who need postoperative intensive care
• Patients who are not planned to be extubated in the operating room

Sponsors & Collaborators

• Ahmet Yuksek: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41100, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 14524640 RESULT

• 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.

  PMID: 34465469 RESULT

• 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.

  PMID: 29500559 RESULT

• 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.

  PMID: 24287327 RESULT

• 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.

  PMID: 31557307 RESULT

• 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.

  PMID: 14980921 RESULT

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Ahmet YUKSEK, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Proffesor, MD

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 28, 2024
• Study Start: January 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 30, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)