Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510803
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Sevoflurane Concentrations in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sevoflurane Concentrations During Induction of Anesthesia With the Drager Apollo and GE Ohmeda Workstations in Children
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The sevoflurane concentrations as well as vital signs childs date of birth type of surgery will be recorded during the first 10 minutes of anesthesia
Detailed Description:
Protocol definition
This study will not deviate from standard anesthetic management of children with the exception of recording the childs vital signs and anesthetic gas concentrations during the anesthetic induction
Healthy children 2-6 years of age fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Childrens Hospital in Buffalo NY will be consented for this protocol by the principal investigator Parents who speak English will be approached for consent the formal hospital translator service will be used for those parents who do not speak English The medical translator will translate the consent form for the parents
Children will be selected for inclusion in this study from the elective surgery list A total of 28 children of both sexes will be enrolled 14 with each of the two workstations We will strive to include the workstation in each operating room at least once in the study The choice of anesthesia workstations Drager Apollo or GE Ohmeda is predetermined by the floor on which the surgery is planned Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei
Once the standard anesthesia monitors are applied the children will undergo a routine inhalational induction that begins with a mixture of 5 litersminute nitrous oxide and 2 litersminute oxygen Once the end-tidal nitrous oxide concentration reaches 045 the sevoflurane vaporizer will be dialed to 8 The inspired and expired concentrations of sevoflurane will be recorded at the designated times see data collection sheet for the first 10 minutes of anesthesia All vital signs oxygen saturation end-tidal carbon dioxide tension blood pressure and heart rate will also be recordedAll unusual movements and airway responses will also be recorded and when they occurred under Notes on the data collection form At the conclusion of the 10 minutes of the induction the airway will be secured with an airway device the surgery will proceed as planned and the recording will cease The study will be terminated
The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Students t-test at a significance level of Plt005
Jerrold Lerman MD FRCPC FANZCA July 11 2024
This study will not deviate from standard anesthetic management of children with the exception of recording the childs vital signs and anesthetic gas concentrations during the anesthetic induction
Healthy children 2-6 years of age fasting and unmedicated scheduled to undergo minor elective surgery under general anesthesia at Oishei Childrens Hospital in Buffalo NY will be consented for this protocol by the principal investigator Parents who speak English will be approached for consent the formal hospital translator service will be used for those parents who do not speak English The medical translator will translate the consent form for the parents
Children will be selected for inclusion in this study from the elective surgery list A total of 28 children of both sexes will be enrolled 14 with each of the two workstations We will strive to include the workstation in each operating room at least once in the study The choice of anesthesia workstations Drager Apollo or GE Ohmeda is predetermined by the floor on which the surgery is planned Drager Apollo workstations are deployed in each of the 7 pediatric operating rooms on the second floor at Oishei and GE Ohmeda workstations are deployed in each of the 5 pediatric operating rooms on the third floor at Oishei
Once the standard anesthesia monitors are applied the children will undergo a routine inhalational induction that begins with a mixture of 5 litersminute nitrous oxide and 2 litersminute oxygen Once the end-tidal nitrous oxide concentration reaches 045 the sevoflurane vaporizer will be dialed to 8 The inspired and expired concentrations of sevoflurane will be recorded at the designated times see data collection sheet for the first 10 minutes of anesthesia All vital signs oxygen saturation end-tidal carbon dioxide tension blood pressure and heart rate will also be recordedAll unusual movements and airway responses will also be recorded and when they occurred under Notes on the data collection form At the conclusion of the 10 minutes of the induction the airway will be secured with an airway device the surgery will proceed as planned and the recording will cease The study will be terminated
The inspired and expired concentrations of Sevoflurane with the Drager Apollo and GE Ohmeda workstations over time will be summarized and displayed graphically The maximum inspired concentrations of Sevoflurane during each induction with the two types of workstations will be compared using Students t-test at a significance level of Plt005
Jerrold Lerman MD FRCPC FANZCA July 11 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None