Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06400706
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-06
First Post:
2024-04-21
Brief Title:
Effect of Electroencephalography Guided General Anesthesia on Postoperative Delirium in Children
Sponsor:
Aydin Adnan Menderes University
Organization:
Aydin Adnan Menderes University
Study Overview
Official Title:
Effect of Electroencephalography SEF and PSI Guided General Anesthesia on Postoperative Delirium and Anesthetic Consumption in Children Underwent Dental Rehabilitation A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
Participants aged 4-10 years 92 patients who came to the Hospital Operating Room at the University Faculty of Dentistry with an indication for dental treatment under general anesthesia due to lack of cooperation will be selected by simple randomization and divided into 2 groups One group of participants who will undergo routine general anesthesia and dental treatment procedures will receive routine monitoring Group I and the other group will receive EEG monitoring Group II in addition to routine monitoring Electrocardiography ECG oxygen saturation SpO2 non-invasive blood pressure NIBP endtidal carbon dioxide EtCO2 endtidal sevoflurane EtSev parameters observed as routine monitoring of the patients will be recorded and the minimal alveolar concentration MAC value will be kept at 09 Anesthesia management will be performed and in Group II in addition to routine monitoring anesthesia management will be carried out to keep the SEF values observed in the EEG between 10-15 and PSI values between 25-50 Routine general anesthesia procedures and dental treatments will not differ between groups
Age gender weight intubation type ASA previous surgical experience anesthesia duration number of extracted teeth with decayed fillings dmft values will also be recorded
In the intraoperative period hemodynamic parameters average heart rate blood pressure and oxygen saturation values and amounts of medication consumed most tidal sevoflurane percentages in induction and maintenance presence of burst suppression sevofluranefentanylrocuronium consumption The participants whose operation is completed will be taken to the recovery room and any post-operative discomfort will be noted The cases will be recorded in the report form
In the postoperative period Extubation time agitation PAED scores and pain FLACC VAS-ORF scores will be recorded during extubation and 10 20 30 minutes and 2 hours after extubation and recovery time hospital stay presence of nausea and vomiting will also be recorded
Modified Aldrete Recovery Score MAS will be used for recovery criteria and MAS 8 will be considered as a recovery indicator The Pediatric Anesthesia Early Delirium Scale PAED will be used to evaluate early agitation FLACC and VAS-ORF scale will be used as pain scales
Age gender weight intubation type ASA previous surgical experience anesthesia duration number of extracted teeth with decayed fillings dmft values will also be recorded
In the intraoperative period hemodynamic parameters average heart rate blood pressure and oxygen saturation values and amounts of medication consumed most tidal sevoflurane percentages in induction and maintenance presence of burst suppression sevofluranefentanylrocuronium consumption The participants whose operation is completed will be taken to the recovery room and any post-operative discomfort will be noted The cases will be recorded in the report form
In the postoperative period Extubation time agitation PAED scores and pain FLACC VAS-ORF scores will be recorded during extubation and 10 20 30 minutes and 2 hours after extubation and recovery time hospital stay presence of nausea and vomiting will also be recorded
Modified Aldrete Recovery Score MAS will be used for recovery criteria and MAS 8 will be considered as a recovery indicator The Pediatric Anesthesia Early Delirium Scale PAED will be used to evaluate early agitation FLACC and VAS-ORF scale will be used as pain scales
Detailed Description:
Postoperative delirium POD is an acute postoperative behavioral change defined as an impairment in the childs awareness or attention to the environment accompanied by disorientation and perceptual changes including hypersensitivity to stimuli and hyperactive motor behavior usually in the immediate post-anesthesia period The incidence of POD may depend largely on age anesthesia technique surgical procedure and adjunctive medication administration Its incidence in preschool children receiving sevoflurane anesthesia varies between 10-80 Although POD is mostly self-limiting and occurs within the first minutes of the postoperative period physical injuries cannot be ignored as children can move their limbs uncontrollably get rid of their catheters and even lose important equipment
Prevention of POD includes pharmacological treatment and non-pharmacological treatment Pharmacological treatment including the administration of midazolam ketamine dexmedetomidine and melatonin in the preoperative or intraoperative period is effective but these measures can prolong the stay in the postoperative anesthesia care unit PACU and cause many adverse reactions such as postoperative nausea and vomiting respiratory depression Non-pharmacological treatments such as parental companionship preoperative education or playing music upon entering the room offer therapeutic effects at lower cost and greater convenience Therefore finding ways to prevent POD using non-pharmacological treatments is valuable
Nowadays more and more anesthesiologists titrate the anesthesia dose by monitoring the depth of anesthesia In 2020 electroencephalography EEG monitoring was recommended by the American Society of Anesthesiologists ASA as one of the important organ monitoring methods to guide general anesthesia management In the adult population the potential benefits of monitoring intraoperative depth of anesthesia have been confirmed including a lower incidence of hypotension under anesthesia and intraoperative awareness faster awakening and recovery time and reduced drug dosage use Many meta-analyses have shown that anesthesia management through EEG monitoring can reduce the occurrence of POD in adult patients undergoing general anesthesia EEG and depth of anesthesia monitoring have been used in pediatric anesthesia management since 2000 It is especially recommended for use in children who have undergone major or long-term surgery EEG monitoring in pediatric anesthesia has been proven to be beneficial for children by reducing anesthetic consumption Pediatric routine anesthesia management largely depends on the experience of the anesthesiologist
Xu et al reported that in pediatric surgery EEG parameters SEF spectral edge frequency PSI patient state index DSA density spectral array and raw EEG waves may be more effective than special indices in reflecting the depth of anesthesia Recent studies have also reported that SEF may be more effective in representing the depth of anesthesia and that DSA can be used as a measure of the depth of anesthesia in young children undergoing sevoflurane anesthesia In addition in the studies of Koch et al raw EEG features were analyzed in children undergoing general anesthesia and some relationships were found between POD and EEG epileptiform discharges However it is still unclear whether the use of these EEG parameters SEF DSA raw EEG wave can reduce the incidence of POD
In this study the investigators used SEF PSI DSA and EEG waves to monitor the depth of anesthesia in children SEF PSI DSA and raw EEG waves can reflect the depth of anesthesia more precisely The aim is to investigate whether the use of SEF DSA and EEG wave measurement to guide and manage pediatric anesthesia can reduce the incidence of POD and anesthesia consumption
Prevention of POD includes pharmacological treatment and non-pharmacological treatment Pharmacological treatment including the administration of midazolam ketamine dexmedetomidine and melatonin in the preoperative or intraoperative period is effective but these measures can prolong the stay in the postoperative anesthesia care unit PACU and cause many adverse reactions such as postoperative nausea and vomiting respiratory depression Non-pharmacological treatments such as parental companionship preoperative education or playing music upon entering the room offer therapeutic effects at lower cost and greater convenience Therefore finding ways to prevent POD using non-pharmacological treatments is valuable
Nowadays more and more anesthesiologists titrate the anesthesia dose by monitoring the depth of anesthesia In 2020 electroencephalography EEG monitoring was recommended by the American Society of Anesthesiologists ASA as one of the important organ monitoring methods to guide general anesthesia management In the adult population the potential benefits of monitoring intraoperative depth of anesthesia have been confirmed including a lower incidence of hypotension under anesthesia and intraoperative awareness faster awakening and recovery time and reduced drug dosage use Many meta-analyses have shown that anesthesia management through EEG monitoring can reduce the occurrence of POD in adult patients undergoing general anesthesia EEG and depth of anesthesia monitoring have been used in pediatric anesthesia management since 2000 It is especially recommended for use in children who have undergone major or long-term surgery EEG monitoring in pediatric anesthesia has been proven to be beneficial for children by reducing anesthetic consumption Pediatric routine anesthesia management largely depends on the experience of the anesthesiologist
Xu et al reported that in pediatric surgery EEG parameters SEF spectral edge frequency PSI patient state index DSA density spectral array and raw EEG waves may be more effective than special indices in reflecting the depth of anesthesia Recent studies have also reported that SEF may be more effective in representing the depth of anesthesia and that DSA can be used as a measure of the depth of anesthesia in young children undergoing sevoflurane anesthesia In addition in the studies of Koch et al raw EEG features were analyzed in children undergoing general anesthesia and some relationships were found between POD and EEG epileptiform discharges However it is still unclear whether the use of these EEG parameters SEF DSA raw EEG wave can reduce the incidence of POD
In this study the investigators used SEF PSI DSA and EEG waves to monitor the depth of anesthesia in children SEF PSI DSA and raw EEG waves can reflect the depth of anesthesia more precisely The aim is to investigate whether the use of SEF DSA and EEG wave measurement to guide and manage pediatric anesthesia can reduce the incidence of POD and anesthesia consumption
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