Ignite Creation Date:
2024-05-06 @ 3:55 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04802122
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2021-03-14
Brief Title:
Induction of Anesthesia With Sevoflurane Preserving Spontaneous Breathing Cardiorespiratory Effects
Sponsor:
Aristotle University Of Thessaloniki
Organization:
Aristotle University Of Thessaloniki
Study Overview
Official Title:
Comparative Assessment of Intubating Conditions and Cardiorespiratory Effects of Sevoflurane Induction and Intubation
Status:
COMPLETED
Status Verified Date:
2021-08
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:
Airway management is of outmost importance in the perioperative period One of the main questions while making a plan for airway management is whether spontaneous ventilation should be maintained or not Induction of anesthesia with Sevoflurane is a conventional technique that preserves spontaneous ventilation It is used especially in non-collaborating patients or when other pharmaceutical agents or sophisticated airway management equipment is out of reach
Inhalational induction of anesthesia with Sevoflurane is well studied However there are few studies investigating the effects of Sevoflurane on induction and intubating conditions on cardiopulmonary physiology on emergence conditions when it is used as one and only agent to achieve induction of anesthesia intubation and maintenance of anesthesia in adult patients There is also no consensus on the appropriate duration of the inhalational induction or other criteria to guarantee successful intubation conditions since most studies investigate Sevoflurane administration until induction of anesthesia and not until intubation
From all the above it appears that there are a few gaps in the management of patients who are to be intubated with Sevoflurane only without the use of any other anesthetic agents
Inhalational induction of anesthesia with Sevoflurane is well studied However there are few studies investigating the effects of Sevoflurane on induction and intubating conditions on cardiopulmonary physiology on emergence conditions when it is used as one and only agent to achieve induction of anesthesia intubation and maintenance of anesthesia in adult patients There is also no consensus on the appropriate duration of the inhalational induction or other criteria to guarantee successful intubation conditions since most studies investigate Sevoflurane administration until induction of anesthesia and not until intubation
From all the above it appears that there are a few gaps in the management of patients who are to be intubated with Sevoflurane only without the use of any other anesthetic agents
Detailed Description:
Preoperatively the study protocol-mandated baseline data will be recorded gender age body weight body mass index body surface area ASA-PS type of surgery The airway assessment will include Mallampati score thyromental distance cervical spine mobility upper lip bite test mouth opening micrognathia protruding incisors beard denture snoring
Patients will be randomly allocated into one of two groups the S group was to be intubated after inhalational anesthesia with Sevoflurane only and maintenance of anesthesia with Sevoflurane 1MAC The P group will receive standard anesthesia induction with propofol 15mgKg fentanyl 2mcgKg rocuronium 05mgKg while anesthesia will be maintained by sevoflurane
Before induction of anesthesia we will record baseline data including BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate and arterial blood gas sample recordings
During induction of anesthesia the following data will be recorded BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate recordings from arterial blood gas sample induction to anesthesia conditions limb movement cough salivation laryngospasm and apnea respiratory rate tidal volume minute volume end-tidal CO2 the concentration of sevoflurane inhaled exhaled peak inspiratory pressure mean inspiratory pressure dynamic respiratory compliance In the S group these data will be recorded again five minutes after the induction to anesthesia commencement
During intubation we will record BIS SpO2 heart rate blood pressure cardiac output stroke volume stroke volume variation intubating conditions jaw relaxation vocal cord position vocal cord movement limb movement bucking Cormack-Lehane grade duration of intubation
After intubation we will register BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate recordings from arterial blood gas sample respiratory rate tidal volume minute volume end-tidal CO2 the concentration of sevoflurane inhaled exhaled peak inspiratory pressure mean inspiratory pressure dynamic respiratory compliance were recorded Patients having abolished spontaneous breathing will be set on the IMV mode of ventilation receiving tidal volume 8mlKg 10 breathsmin PEEP5cmH2O I E12 Plateau time 30
Upon the end of the surgical stimuli the following parameters will be registered BIS blood pressure heart rate SpO2 stroke volume stroke volume variation cardiac output etCO2 respiratory rate sevoflurane concentration exhaled inhaled peak inspiratory pressure mean inspiratory pressure dynamic compliance time of establishing spontaneous breathing time of extubation
BIS blood pressure heart rate SpO2 stroke volume stroke volume variation cardiac output etCO2 the respiratory rate will be recorded 5 and 10 minutes respectively post-extubation
Patients will be randomly allocated into one of two groups the S group was to be intubated after inhalational anesthesia with Sevoflurane only and maintenance of anesthesia with Sevoflurane 1MAC The P group will receive standard anesthesia induction with propofol 15mgKg fentanyl 2mcgKg rocuronium 05mgKg while anesthesia will be maintained by sevoflurane
Before induction of anesthesia we will record baseline data including BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate and arterial blood gas sample recordings
During induction of anesthesia the following data will be recorded BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate recordings from arterial blood gas sample induction to anesthesia conditions limb movement cough salivation laryngospasm and apnea respiratory rate tidal volume minute volume end-tidal CO2 the concentration of sevoflurane inhaled exhaled peak inspiratory pressure mean inspiratory pressure dynamic respiratory compliance In the S group these data will be recorded again five minutes after the induction to anesthesia commencement
During intubation we will record BIS SpO2 heart rate blood pressure cardiac output stroke volume stroke volume variation intubating conditions jaw relaxation vocal cord position vocal cord movement limb movement bucking Cormack-Lehane grade duration of intubation
After intubation we will register BIS SpO2 heart rate invasive blood pressure cardiac output stroke volume stroke volume variation respiratory rate recordings from arterial blood gas sample respiratory rate tidal volume minute volume end-tidal CO2 the concentration of sevoflurane inhaled exhaled peak inspiratory pressure mean inspiratory pressure dynamic respiratory compliance were recorded Patients having abolished spontaneous breathing will be set on the IMV mode of ventilation receiving tidal volume 8mlKg 10 breathsmin PEEP5cmH2O I E12 Plateau time 30
Upon the end of the surgical stimuli the following parameters will be registered BIS blood pressure heart rate SpO2 stroke volume stroke volume variation cardiac output etCO2 respiratory rate sevoflurane concentration exhaled inhaled peak inspiratory pressure mean inspiratory pressure dynamic compliance time of establishing spontaneous breathing time of extubation
BIS blood pressure heart rate SpO2 stroke volume stroke volume variation cardiac output etCO2 the respiratory rate will be recorded 5 and 10 minutes respectively post-extubation
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