Anesthesia Intubation ComplicationPhase 4NCT04802122
Induction of Anesthesia With Sevoflurane Preserving Spontaneous Breathing: Cardiorespiratory Effects.
A Phase 4 study testing Sevoflurane inhalant product and Propofol Fresenius in people with Anesthesia Intubation Complication and Cardiovascular Complication, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anesthesia Intubation Complication, Cardiovascular Complication, Intubation
- What is being tested?
- Sevoflurane inhalant product and Propofol Fresenius
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 24 May 2021to 14 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 and < 71 years
- ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
- General anesthesia for abdominal surgery
- Elective cases
- Signed informed consent
Who cannot join
- Urgent/emergency surgeries
- BMI<18.5 or BMI>34.9
- Intraabdominal hypertension
- Gastroesophageal reflex
- Pregnancy
- Liver or renal failure
- intracranial hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Assessment of Intubating Conditions and Cardiorespiratory Effects of Sevoflurane Induction and Intubation.
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.
Read the 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 1,5mg/Kg, fentanyl 2mcg/Kg, rocuronium 0,5mg/Kg, 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 8ml/Kg, 10 breaths/min, PEEP=5cmH2O, I: E=1:2, 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.
- Being tested
- Sevoflurane inhalant product, Propofol Fresenius
- Keywords
- inhalational, sevoflurane, cardiovascular, induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane inhalant productDrug
Also called Sevoflurane
Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation.
Propofol FreseniusDrug
Also called Propofol
Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. .
| Study group | Role | What they receive |
|---|---|---|
| Sevoflurane group | Experimental | Patients in this group will receive Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) for induction to anesthesia and to facilitate endotracheal intubation (without the use of muscle relaxant) and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia plus muscle relaxant until study completion. Receives: Drug: Sevoflurane inhalant product |
| Propofol group | Active comparator | Patients in this group will receive a standard anesthesia induction involving Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% for induction to anesthesia and to facilitate endotracheal intubation and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia. Receives: Drug: Propofol Fresenius |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intubating conditions
Modification of intubating conditions assessed by Cormack-Lehane classification system after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
Measured: 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Cardiac output compromise
Cardiac index reduction defined CI < 2.2 L/min/m2 after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
Measured: Within 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Secondary outcomes (2)
Hypercapnia
The occurrence of hypercapnia defined as carbon dioxide partial pressure > 45 mmHg in arterial blood gas sample after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
Measured: 1 minute after intubation
Hypotension
Duration of hypotension defined as systemic arterial pressure < 90mmHg after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
Measured: Within10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start24 May 2021
- Primary completion13 Jul 2021
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia Intubation ComplicationStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgia Tsaousi, Aristotle University Of Thessaloniki
- Investigators
- Vasilios Grosomanidis, Study director, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802122
- Sponsor's protocol ID
- INTUSEVO
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2021
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Assessment of Intubating Conditions and Cardiorespiratory Effects of Sevoflurane Induction and Intubation.
- ClinicalTrials.gov ID
- NCT04802122
- Acronym / sponsor ID
- INTUSEVO
- Keywords
- inhalational, sevoflurane, cardiovascular, induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 1,5mg/Kg, fentanyl 2mcg/Kg, rocuronium 0,5mg/Kg, 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 8ml/Kg, 10 breaths/min, PEEP=5cmH2O, I: E=1:2, 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sevoflurane group | Experimental | Drug: Sevoflurane inhalant productPatients in this group will receive Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) for induction to anesthesia and to facilitate endotracheal intubation (without the use of muscle relaxant) and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia plus muscle relaxant until study completion. |
| Propofol group | Active comparator | Drug: Propofol FreseniusPatients in this group will receive a standard anesthesia induction involving Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% for induction to anesthesia and to facilitate endotracheal intubation and thereafter Sevoflurane 1 MAC will be used for maintenance of anesthesia. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 and < 71 years
- ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
- General anesthesia for abdominal surgery
- Elective cases
- Signed informed consent
Key exclusion criteria (7 listed)
- Urgent/emergency surgeries
- BMI<18.5 or BMI>34.9
- Intraabdominal hypertension
- Gastroesophageal reflex
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sevoflurane inhalant productAlso: SevofluraneSevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation. | Drug | Sevoflurane group |
| Propofol FreseniusAlso: PropofolPropofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. . | Drug | Propofol group |
Primary outcome
Intubating conditions
Time frame: 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Modification of intubating conditions assessed by Cormack-Lehane classification system after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
Cardiac output compromise
Time frame: Within 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Cardiac index reduction defined CI < 2.2 L/min/m2 after induction to anesthesia with sevoflurane (without muscle relaxants) or standard induction to anesthesia involving propofol supplemented by fentanyl and muscle relaxant.
2 secondary outcomes
Hypercapnia
Time frame: 1 minute after intubation
Hypotension
Time frame: Within10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasilios Grosomanidis study director
Aristotle University Of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane inhalant product and Propofol Fresenius in people with Anesthesia Intubation Complication and Cardiovascular Complication, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intubating conditions (time frame: 10 minutes after induction to anesthesia commencement with sevoflurane or 5 minutes after induction to anesthesia with propofol plus fentanyl and muscle relaxant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2021.