Bispectral Index, Suppression Rate and Emergence Agitation in Spine Surgeries

Emergence Agitation Clinical Trial

Official title:

Bispectral Index, Suppression Rate and Recovery Agitation in Spine Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06334939
• Other study ID #: KSH.2023-32
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: August 30, 2024

Study information

• Verified date: June 2024
• Source: Kocaeli City Hospital
• Contact: Ahmet YUKSEK, MD
• Phone: +90-532-6580351
• Email: ahmet.yuksek[@]yobu.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 30, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia Recovery
• Bispectral Index Monitor
• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Turkey	Kocaeli City Hospital	Kocaeli	Izmit

Sponsors (1)

Lead Sponsor	Collaborator
Ahmet Yuksek

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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 — View 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 Anaest — View 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 — View 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. — View 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 — View 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.resuscita — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	First 1 hour postoperative