NCT06217341|Unknown
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Sponsor study identifier
observational
60
1 country
1
Study Start
December 29, 2023
Actual (reported)Primary Completion
March 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Recovery and emergence agitation is a problem that occurs after anesthesia and requires urgent intervention. The effects of changes in EEG waves during anesthesia or undesirable deep periods in Bispectral index (BIS) monitoring on recovery agitation are the subject of this research.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 29, 2023
Actual (reported)January 2, 2024
Actual (reported)January 22, 2024
Actual (reported)March 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The relationship between BIS-SR values and post-anesthesia recovery (Richmond agitation sedation score) and recovery time
The relationship between the maximum BIS-SR value or the time of SR\>10 points and recovery times and recovery agitation (Richmond agitation sedation score) will be investigated.
intraoperative period and postoperative first 4 hours
The relationship between Bis values and recovery agitation (Richmond agitation sedation score)
intraoperative period and postoperative first 4 hours
Patients in the emergence agitation group are patients who are observed to be agitated during recovery according to the Richmond agitation sedation scale after anesthesia.
The calm group will consist of patients whose agitation scale is below +2 during recovery.
Perioperative Bispectral Index Monitoring (BIS) monitor and Bispectral Index suppression Rate (BIS-SR) monitoring will be applied. The duration and magnitude of BIS-SR values will be examined together with BIS values in terms of recovery agitation.
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The current research was designed as a prospective observational study. Routine anesthesia procedures will be applied to patients who will undergo lumbar disc herniation surgery and who have agreed to participate in the study, and the routinely recorded recovery scale will be recorded for the study.
Kocaeli City Hospital
Kocaeli, 41010, Turkey (Türkiye)
Cornelius BW, Jacobs TM. Pseudocholinesterase Deficiency Considerations: A Case Study. Anesth Prog. 2020 Sep 1;67(3):177-184. doi: 10.2344/anpr-67-03-16.
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.
Ahmet YUKSEK, Md
Kocaeli City Hospital
First Submitted
January 2, 2024
First Posted
January 22, 2024
Study Start
December 29, 2023
Actual (reported)Primary Completion
March 29, 2024
Estimated (date passed)Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy
Contact the study team to confirm eligibility.
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.
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.
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.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 29, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 22, 2024
Record last verified: 2024-01
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