Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06323616
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-15
Brief Title:
The Effect of Anesthesia Depth Monitoring on Emergence Delirium in Pediatrics
Sponsor:
Istanbul University
Organization:
Istanbul University
Study Overview
Official Title:
The Effect of Anesthesia Depth Monitoring on Emergence Agitation and Delirium in Pediatrics
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some changes in the patients cognitive state are observed during the recovery period from general anesthesia This period of behavioral dysregulation has been called emergence agitation EA and emergence delirium ED ED and EA occur in the early postoperative period often within the first 30 minutes The incidence of ED ranges from 10 to 80 in children and is described as a distressing clinical condition by 42 of pediatric anesthesiologists Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia but its use is associated with the occurrence of ED in the pediatric population Clinical findings are characterized by hallucinations struggling restlessness crying and disorientation
In the literature the Pediatric Anesthesia Rescue Delirium PAED Scale Score is used in the diagnosis of ED and EA This score consists of 5 criteria maximum score 20 scored using 0-4 point scales These criteria The child needs to make eye contact with the caregiver the childs movements are purposeful the child is aware of the environment the child is restlessangry the child cannot be consoled While the sensitivity of 10 points for the diagnosis of ED is 64 and the specificity is 86 the sensitivity of 12 points for the diagnosis of ED is 100 and the specificity is 945
Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists ASA due to its potential benefits such as faster recovery time and lower drug dosage as well as prevention of adverse effects such as the incidence of hypotension The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics
There are very few studies in the literature on the relationship between anesthesia depth monitoring and EAED in children and further studies are needed
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia but its use is associated with the occurrence of ED in the pediatric population Clinical findings are characterized by hallucinations struggling restlessness crying and disorientation
In the literature the Pediatric Anesthesia Rescue Delirium PAED Scale Score is used in the diagnosis of ED and EA This score consists of 5 criteria maximum score 20 scored using 0-4 point scales These criteria The child needs to make eye contact with the caregiver the childs movements are purposeful the child is aware of the environment the child is restlessangry the child cannot be consoled While the sensitivity of 10 points for the diagnosis of ED is 64 and the specificity is 86 the sensitivity of 12 points for the diagnosis of ED is 100 and the specificity is 945
Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists ASA due to its potential benefits such as faster recovery time and lower drug dosage as well as prevention of adverse effects such as the incidence of hypotension The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics
There are very few studies in the literature on the relationship between anesthesia depth monitoring and EAED in children and further studies are needed
Detailed Description:
During the compilation period after general anesthesia cognitive status changes called emergence agitation and emergence delirium clinically characterized by hallucinations struggling restlessness crying and disorientation are observed ED and EA often occur in the early postoperative period especially in the first 30 minutes
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia but its use is associated with the occurrence of EDEA in the pediatric population In our study we aimed to determine the effect of sevoflurane anesthesia on the incidence of EDEA under anesthesia depth monitoring
Patients who give informed consent will be divided into 2 groups and randomized using the opaque sealed envelope method
Children participating in the study will be evaluated with mYPAS an anxiety assessment scale in the preoperative period Studies have found that children with high levels of anxiety have a higher frequency of developing maladaptive behavioral changes pain and ED after surgery
On the day of surgery patients will be taken to the operating room after premedication with 05 mgkg po midazolam Following routine noninvasive blood pressure saturation and ECG monitoring PEEG monitoring will be carried out with the help of pediatric sensors Anesthesia guided by PEEG processed electroencephalography contributes to optimal targeting of the depth of anesthesia The rationale for PEEG is to provide a simplified method for monitoring the depth of anesthesia through rapid interpretation of the frontal electroencephalogram EEG Thus 4-channel raw EEG L1 R1 L2 and R2 - equivalent to Fp1 F7 Fp2 and F8 according to the standard EEG monitoring system electrode impedance patient condition index PSI left and right spectral edge frequency SEF95 and burst suppression ratio SR can be achieved PSI It is a dimensionless depth of anesthesia index that combines weighted quantitative EEG parameters reflecting multiple dimensions of brain electrical activity The correct depth of anesthesia is determined by the PSI value between 25 and 50
Following inhaler induction with 8 sevoflurane 05 mgkg rocuronium and 2 mcgkg fentanyl will be administered iv Anesthesia maintenance of the patients will be provided with sevoflurane and 002-01mcgkgmin remifentanil iv infusion
To the control group As we apply in routine anesthesia practice sevoflurane anesthesia will be applied with Endtidal agent consumption of 08 MACage for MACage1 with 2 standard deviations During the surgery parameters indicating the depth of anesthesia will be placed away from the anesthesiologist and closed to ensure blindness At the end of the surgery the data will be received via USB
As for the working group Sevoflurane anesthesia will be applied by adjusting the MAC so that the PSI median value remains between 25-50 if PSI25 MAC will be reduced by 01 if PSI50 MAC will be increased by 01
At the end of inhalation anesthesia regional anesthesia peripheral nervebody block will be applied to both groups for postoperative analgesia
At the end of the operation the PAED scores of all children 5 15 and 30 minutes after extubation will be evaluated and recorded by PACU post-anesthesia care unit nurses who are blind to the study groups
Ped-PADSS score defined as the discharge score will be checked at 30 45 and 60 minutes in the compilation room This score consists of 5 criteria which are vital signs activity level nausea-vomiting presence of pain 6 years OPS 6 years VAS and surgical bleeding It is evaluated between 0 and 10 points 9 points and above are safe for discharge from the compilation room
In the post-hospital discharge period the PHBQ scale will be administered to patients via an online survey on days 3 14 and 28 This scale is a post-discharge behavior scale developed for children consisting of six subscales general anxiety separation anxiety sleep eating aggression apathy and 27 questions Values between 27-135 points will be recorded and evaluated in terms of whether late-term behavioral changes occur
There is little data in the literature on the relationship between anesthesia depth monitoring and ED during recovery in children and further studies are needed In our study we think that the frequency of ED will be less in the study group than in the control group
Sevoflurane is a widely used agent for the induction and maintenance of anesthesia but its use is associated with the occurrence of EDEA in the pediatric population In our study we aimed to determine the effect of sevoflurane anesthesia on the incidence of EDEA under anesthesia depth monitoring
Patients who give informed consent will be divided into 2 groups and randomized using the opaque sealed envelope method
Children participating in the study will be evaluated with mYPAS an anxiety assessment scale in the preoperative period Studies have found that children with high levels of anxiety have a higher frequency of developing maladaptive behavioral changes pain and ED after surgery
On the day of surgery patients will be taken to the operating room after premedication with 05 mgkg po midazolam Following routine noninvasive blood pressure saturation and ECG monitoring PEEG monitoring will be carried out with the help of pediatric sensors Anesthesia guided by PEEG processed electroencephalography contributes to optimal targeting of the depth of anesthesia The rationale for PEEG is to provide a simplified method for monitoring the depth of anesthesia through rapid interpretation of the frontal electroencephalogram EEG Thus 4-channel raw EEG L1 R1 L2 and R2 - equivalent to Fp1 F7 Fp2 and F8 according to the standard EEG monitoring system electrode impedance patient condition index PSI left and right spectral edge frequency SEF95 and burst suppression ratio SR can be achieved PSI It is a dimensionless depth of anesthesia index that combines weighted quantitative EEG parameters reflecting multiple dimensions of brain electrical activity The correct depth of anesthesia is determined by the PSI value between 25 and 50
Following inhaler induction with 8 sevoflurane 05 mgkg rocuronium and 2 mcgkg fentanyl will be administered iv Anesthesia maintenance of the patients will be provided with sevoflurane and 002-01mcgkgmin remifentanil iv infusion
To the control group As we apply in routine anesthesia practice sevoflurane anesthesia will be applied with Endtidal agent consumption of 08 MACage for MACage1 with 2 standard deviations During the surgery parameters indicating the depth of anesthesia will be placed away from the anesthesiologist and closed to ensure blindness At the end of the surgery the data will be received via USB
As for the working group Sevoflurane anesthesia will be applied by adjusting the MAC so that the PSI median value remains between 25-50 if PSI25 MAC will be reduced by 01 if PSI50 MAC will be increased by 01
At the end of inhalation anesthesia regional anesthesia peripheral nervebody block will be applied to both groups for postoperative analgesia
At the end of the operation the PAED scores of all children 5 15 and 30 minutes after extubation will be evaluated and recorded by PACU post-anesthesia care unit nurses who are blind to the study groups
Ped-PADSS score defined as the discharge score will be checked at 30 45 and 60 minutes in the compilation room This score consists of 5 criteria which are vital signs activity level nausea-vomiting presence of pain 6 years OPS 6 years VAS and surgical bleeding It is evaluated between 0 and 10 points 9 points and above are safe for discharge from the compilation room
In the post-hospital discharge period the PHBQ scale will be administered to patients via an online survey on days 3 14 and 28 This scale is a post-discharge behavior scale developed for children consisting of six subscales general anxiety separation anxiety sleep eating aggression apathy and 27 questions Values between 27-135 points will be recorded and evaluated in terms of whether late-term behavioral changes occur
There is little data in the literature on the relationship between anesthesia depth monitoring and ED during recovery in children and further studies are needed In our study we think that the frequency of ED will be less in the study group than in the control group
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None