Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06560268
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Low Flow Anesthesia in Children Undergoing Strabismus Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Different Fresh Gas Flows on Emergence Agitation and Anesthetic Agent Consumption in Children Undergoing Strabismus Surgery
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:
LFA in child
Brief Summary:
Emergence agitation EA involves restlessness disorientation excitation non-purposeful movement inconsolability thrashing and incoherence during early recovery from general anesthesia Sevoflurane and desflurane have increased the incidence of EA in children A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function due to differences in clearance of inhalational anesthetics from the central nervous system whereas audition and locomotion recover first cognitive function recovers later resulting in EA Low-flow anaesthesia LFA occurs when the fresh gas flow FGF is significantly lower than the patients minute volume In a low-flow system the recirculated fraction should amount to at least 50 after carbon dioxide CO2 absorptionIn LFA using minimal FGF 250-500 mLmin if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more In a study conducted on infants undergoing cleft lip-palate surgery it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 05 Lmin FGF
Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA 40-86 The incidence of EA after strabismus surgery is high especially due to visual disturbances however the pathogenesis of this condition remains unclear In our study the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated
Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA 40-86 The incidence of EA after strabismus surgery is high especially due to visual disturbances however the pathogenesis of this condition remains unclear In our study the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated
Detailed Description:
Emergence agitation EA involves restlessness disorientation excitation non-purposeful movement inconsolability thrashing and incoherence during early recovery from general anesthesia The incidence of EA varies from approximately 025 to 905 with age assessment tool used definitions anesthetic techniques type of surgery and time of EA assessment during recovery The clinical consequences of EA are similarly varied It is typically short lived and resolves spontaneously and its clinical consequences are often considered minimal However it may have clinically significant consequences such as injury to the affected patient or their medical staff falling out of bed bleeding at the surgical site accidental removal of drains or intravenous catheters unintended extubation respiratory depression and increasing medical care costs
Sevoflurane and desflurane have increased the incidence of EA in children A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function due to differences in clearance of inhalational anesthetics from the central nervous system whereas audition and locomotion recover first cognitive function recovers later resulting in EA In addition studies on pediatric patients have found that being awakened rapidly by unfamiliar healthcare personnel in an unfamiliar operating room environment is a potential risk factor for EA Rapid clearance of anesthetic agents from subcortical structures locus coeruleus and amygdala before the cerebral cortex and rapid recovery have been suggested as a causal factor for EA Therefore methods to reduce the incidence of EA aim to reduce the concentration difference between cortical and subcortical areas by slowing down the elimination of inhaled anesthetic agents
Low-flow anaesthesia LFA occurs when the fresh gas flow FGF is significantly lower than the patients minute volume In a low-flow system the recirculated fraction should amount to at least 50 after carbon dioxide CO2 absorption There are various techniques for the introduction of the inhaled anesthetic In general they all follow the same sequence nitrogen wash-out a period of higher flow rate in combination with a high vaporizer setting for initial saturation and subsequent reduction of fresh gas flow and adjustment of the vaporizer to maintain the desired end-tidal anesthetic agent concentration Etaa The wash-in period saturation of the central nervous system area where the inhaled agent is effective depends on the initial FGF and the vaporizer setting In the initial wash-in phase the vaporizer setting is adjusted to 6 for desflurane and 25-3 for sevoflurane with FGF 4 Lmin until the Etaa concentration is 1-13 MAC In another method the vaporizer setting is adjusted to 12-18 for desflurane and 6-8 for sevoflurane with FGF 1 Lmin Reducing the FGF during the wash-in period prevents unnecessary depth of anesthesia and reduces the consumption of inhalational anesthetics The wash-in ie the saturation of the gaseous compartment is dependent on the initial fresh gas flow and the vaporizer setting Reducing FGF from 4 to 1 Lmin reduces inhalation anesthetic consumption by 453 desflurane and 518 sevoflurane respectively In parallel there is a significant reduction in CO2e emissions and anesthesia costs per minute of approximately 45-50 When the Etaa concentration is 1-13 MAC the maintenance period is started with a FGF between 025-1 Lmin In LFA using minimal FGF 250-500 mLmin if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more 4-5 In a study conducted on infants undergoing cleft lip-palate surgery it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 05 Lmin FGF
Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA 40-86 The incidence of EA after strabismus surgery is high especially due to visual disturbances however the pathogenesis of this condition remains unclear In our study the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated
METHOD 150 patients aged 3-10 years undergoing strabismus surgery will be included in the study Patients will be randomly divided into three groups Using a 4-point scale preoperative agitation will be evaluated in the reception area and then 005 mgkg intravenous iv midazolam will be administered for premedication
For anesthesia induction all patients will be administered 3 mgkg propofol and 05 mgkg rocuronium and mechanical ventilation will be performed with a laryngeal mask A tidal volume of 6-8 mlkg will be applied and end-tidal CO2 will be maintained between 30-35 mmHg After induction all children will be administered 1 μgkg fentanyl IV In all patients the sevoflurane concentration in the O2 and air mixture will be titrated between MAC 1-13 throughout the operation keeping BIS 40-60 and baseline hemodynamic changes between 20 The inspiratory oxygen concentration FiO2 alarm lower limit will be set to 30 in all patients
Patients will be randomly divided into 3 groups
Group I After the laryngeal mask is placed ventilation will be performed with FGF 4 lmin vaporizer setting will be 25-3 When the patients reach 1 MAC FGF will be reduced to 2 lmin
Group II After the laryngeal mask is placed ventilation will be performed with FGF 4 lmin vaporizer setting will be 25-3 and when the patients reach 1 MAC FGF 05 lmin will be reduced
Group III After the laryngeal mask is placed ventilation will be performed with FGF 1 lmin vaporizer setting will be 8 inhaled sevoflurane concentration Fisevo will be gradually reduced to 4 When the children reach 1 MAC FGF 05 lmin will be reduced
In Group I the vaporizer will be turned off at the end of the operation and FGF will be increased to 10 lmin
In Group II and III the vaporizer will be turned off 10 minutes before the end of the operation and FGF will continue as 05 lmin until the end of the operation
All patients will be assessed by an anesthesiologist who is unaware of the study protocol at postoperative 5 10 15 30 and 45 minutes and at 2 hours using the 5-point Emergence Agitation Scale and the Pediatric Anesthesia Emergence Delirium PAED in the postoperative recovery unit Postoperative pain will be assessed using the Children39s Hospital of Eastern Ontario Pain Scale CHEOPS If the patient39s PAED score is 16 iv fentanyl 1 μgkg will be administered Postoperative adverse events including laryngospasm desaturation SpO295 nausea and vomiting will also be recorded In the recovery unit children with a modified Aldrete anesthesia discharge score gt9 will be transferred to the ward
Sevoflurane and desflurane have increased the incidence of EA in children A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function due to differences in clearance of inhalational anesthetics from the central nervous system whereas audition and locomotion recover first cognitive function recovers later resulting in EA In addition studies on pediatric patients have found that being awakened rapidly by unfamiliar healthcare personnel in an unfamiliar operating room environment is a potential risk factor for EA Rapid clearance of anesthetic agents from subcortical structures locus coeruleus and amygdala before the cerebral cortex and rapid recovery have been suggested as a causal factor for EA Therefore methods to reduce the incidence of EA aim to reduce the concentration difference between cortical and subcortical areas by slowing down the elimination of inhaled anesthetic agents
Low-flow anaesthesia LFA occurs when the fresh gas flow FGF is significantly lower than the patients minute volume In a low-flow system the recirculated fraction should amount to at least 50 after carbon dioxide CO2 absorption There are various techniques for the introduction of the inhaled anesthetic In general they all follow the same sequence nitrogen wash-out a period of higher flow rate in combination with a high vaporizer setting for initial saturation and subsequent reduction of fresh gas flow and adjustment of the vaporizer to maintain the desired end-tidal anesthetic agent concentration Etaa The wash-in period saturation of the central nervous system area where the inhaled agent is effective depends on the initial FGF and the vaporizer setting In the initial wash-in phase the vaporizer setting is adjusted to 6 for desflurane and 25-3 for sevoflurane with FGF 4 Lmin until the Etaa concentration is 1-13 MAC In another method the vaporizer setting is adjusted to 12-18 for desflurane and 6-8 for sevoflurane with FGF 1 Lmin Reducing the FGF during the wash-in period prevents unnecessary depth of anesthesia and reduces the consumption of inhalational anesthetics The wash-in ie the saturation of the gaseous compartment is dependent on the initial fresh gas flow and the vaporizer setting Reducing FGF from 4 to 1 Lmin reduces inhalation anesthetic consumption by 453 desflurane and 518 sevoflurane respectively In parallel there is a significant reduction in CO2e emissions and anesthesia costs per minute of approximately 45-50 When the Etaa concentration is 1-13 MAC the maintenance period is started with a FGF between 025-1 Lmin In LFA using minimal FGF 250-500 mLmin if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more 4-5 In a study conducted on infants undergoing cleft lip-palate surgery it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 05 Lmin FGF
Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA 40-86 The incidence of EA after strabismus surgery is high especially due to visual disturbances however the pathogenesis of this condition remains unclear In our study the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated
METHOD 150 patients aged 3-10 years undergoing strabismus surgery will be included in the study Patients will be randomly divided into three groups Using a 4-point scale preoperative agitation will be evaluated in the reception area and then 005 mgkg intravenous iv midazolam will be administered for premedication
For anesthesia induction all patients will be administered 3 mgkg propofol and 05 mgkg rocuronium and mechanical ventilation will be performed with a laryngeal mask A tidal volume of 6-8 mlkg will be applied and end-tidal CO2 will be maintained between 30-35 mmHg After induction all children will be administered 1 μgkg fentanyl IV In all patients the sevoflurane concentration in the O2 and air mixture will be titrated between MAC 1-13 throughout the operation keeping BIS 40-60 and baseline hemodynamic changes between 20 The inspiratory oxygen concentration FiO2 alarm lower limit will be set to 30 in all patients
Patients will be randomly divided into 3 groups
Group I After the laryngeal mask is placed ventilation will be performed with FGF 4 lmin vaporizer setting will be 25-3 When the patients reach 1 MAC FGF will be reduced to 2 lmin
Group II After the laryngeal mask is placed ventilation will be performed with FGF 4 lmin vaporizer setting will be 25-3 and when the patients reach 1 MAC FGF 05 lmin will be reduced
Group III After the laryngeal mask is placed ventilation will be performed with FGF 1 lmin vaporizer setting will be 8 inhaled sevoflurane concentration Fisevo will be gradually reduced to 4 When the children reach 1 MAC FGF 05 lmin will be reduced
In Group I the vaporizer will be turned off at the end of the operation and FGF will be increased to 10 lmin
In Group II and III the vaporizer will be turned off 10 minutes before the end of the operation and FGF will continue as 05 lmin until the end of the operation
All patients will be assessed by an anesthesiologist who is unaware of the study protocol at postoperative 5 10 15 30 and 45 minutes and at 2 hours using the 5-point Emergence Agitation Scale and the Pediatric Anesthesia Emergence Delirium PAED in the postoperative recovery unit Postoperative pain will be assessed using the Children39s Hospital of Eastern Ontario Pain Scale CHEOPS If the patient39s PAED score is 16 iv fentanyl 1 μgkg will be administered Postoperative adverse events including laryngospasm desaturation SpO295 nausea and vomiting will also be recorded In the recovery unit children with a modified Aldrete anesthesia discharge score gt9 will be transferred to the ward
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