SevofluraneMACEINCT03522402
Effect of Head Position on MACEI of Sevoflurane in Children With Obstructive Airway
A study testing Sevoflurane in people with Sevoflurane and Endotracheal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
Children scheduled for tonsillectomy surgery were recruited into the study. General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal… Read more about this study
- Who is it for?
- Ages 2 to 8 years
- Conditions the study is for
- Sevoflurane, Endotracheal Intubation
- What is being tested?
- Sevoflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Oct 2018
- Phase
- Interventional
- 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 2 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- class I or II
- children aged 2-8 years
- children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
- signed informed consent
Who cannot join
- Patients with a history of adverse reactions to sevoflurane
- Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
- Patients with reactive airway disease
- Signs of upper respiratory infection
- Violate experimental scheme
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation（MACEI）of Sevoflurane in Children With Obstructive Airway
Children scheduled for tonsillectomy surgery were recruited into the study. General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min. All responses to tracheal intubation were assessed. At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake. The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive airway are different from that observed in normal children.
Read the detailed description
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min （L/min） for 1 min. Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration. A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations. Neuromuscular blocking agents and other intravenous anesthetics were not given. One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with intubation score. The sum of intubation scores >4 was defined as a failure of insertion. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the next patient. For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.
- Conditions
- Sevoflurane, Endotracheal Intubation
- Being tested
- Sevoflurane
- Keywords
- head position, obstructive airway, minimum alveolar concentration(MACendotracheal intubation), sevoflurane concentration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Also called 30 degree rotated lateral position and neutral position
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
| Study group | Role | What they receive |
|---|---|---|
| 30 degree rotated lateral position | Experimental | 19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. Receives: Drug: Sevoflurane |
| neutral position | Active comparator | 19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
minimum alveolar anesthetic concentration of endotracheal intubation
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
Measured: The sevoflurane concentration is obtained when tracheal intubated immediately.
Secondary outcomes (4)
intubation score
One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with intubation score. The sum of intubation scores >4 was defined as a failure of insertion.
Measured: The intubation score is obtained when tracheal intubation was inserted immediately.
blood pressure include systolic and diastolic in mmHg
To compare the evolution of blood pressure include systolic and diastolic during different head position group.
Measured: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
heart rate in bpm
To compare the evolution of heart rate during different head position group.
Measured: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
bispectral index（BIS）, number from 100 (awake) to 40-60(anesthetic status)
To compare the evolution of of bispectral index values during different head position group.
Measured: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2018
- Study completion31 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for SevofluraneStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingjie Li, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Li Jing Jie, M.D., Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03522402
- Sponsor's protocol ID
- 2018-15-T15
- Acronym
- MACEI
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.
PubMed 8615504Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.
PubMed 1994760Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.
PubMed 14564561Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.
PubMed 10910489Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.
PubMed 2894106Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.
PubMed 22017661Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
PubMed 9135350
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Head Position on Minimum Alveolar Concentration of Endotracheal Intubation（MACEI）of Sevoflurane in Children With Obstructive Airway
- ClinicalTrials.gov ID
- NCT03522402
- Acronym / sponsor ID
- MACEI / 2018-15-T15
- Conditions
- Sevoflurane, Endotracheal Intubation
- Keywords
- head position, obstructive airway, minimum alveolar concentration(MACendotracheal intubation), sevoflurane concentration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 31 Oct 2018 (estimated)
- First posted
- 11 May 2018 (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.
Children scheduled for tonsillectomy surgery were recruited into the study. General anesthesia was induced with 8% sevoflurane inhaled with 8 l.min-1 of oxygen via mask, followed by adjustment of inspired sevoflurane to the target concentration based on the result in previous patient at which laryngoscopy and tracheal intubation were attempted and maintained for 12 min. All responses to tracheal intubation were assessed. At the end of the procedure, sevoflurane was titrated to the target concentration, which was kept constant for 12 min before a standard stimulus was applied to determine whether the children was awake. The Dixon's 'up and down'method was used to determine progression of subsequent concentrations.The aim of this study was to determine whether the minimum alveolar concentration of endotracheal intubation（MACEI）of sevoflurane in children with obstructive airway are different from that observed in normal children.
Detailed description
38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. All patients were preoxygenated using 100% oxygen with a normal tidal volumen for 3 min. The circuit was primed with sevoflurane 8% at a fresh gas flow of 8 Litre/min （L/min） for 1 min. Anaesthesia was induced with inhaled sevoflurane up to 5% in oxygen via facemask with fresh gas flow at 6 L/min.After loss of consciousness, the inspired concentration of sevoflurane was maintained 10-12min a predetermined end-tidal concentration. A single experienced anaesthetist in the use of endotracheal devices inserted the devices according to the manufacturer's recommendations. Neuromuscular blocking agents and other intravenous anesthetics were not given. One nurse, who was blinded to the anaesthetic concentration, classified responses by the patient to tracheal intubation as either "movement" or "not movement". Assesment was made for jaw relaxation and graded with intubation score. The sum of intubation scores >4 was defined as a failure of insertion. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. If the endotracheal device insertion was successful, sevoflurane concentration for the next patient was decrease by 0.5%. If not, sevoflurane concentration was increased by the same amount for the next patient. For their comfort, patients experiencing movement received a 2 mg/kg bolus dose of propofol,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg.If the endotracheal device insertion was successful,fentanyl 2.0ug/kg and rocuronium 0.6mg/kg was also administered.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 degree rotated lateral position | Experimental | Drug: Sevoflurane19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. |
| neutral position | Active comparator | Drug: Sevoflurane19 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to the head in the neutral position.The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- class I or II
- children aged 2-8 years
- children with obstruction airway under general anesthesia undergoing tonsillectomy surgery
- signed informed consent
Key exclusion criteria (6 listed)
- Patients with a history of adverse reactions to sevoflurane
- Patients with a potentially difficult airway (Mallampati III or IV, a limited mouth opening and/or cervical spine disease)
- Patients with reactive airway disease
- Signs of upper respiratory infection
- Violate experimental scheme
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 |
|---|---|---|
| SevofluraneAlso: 30 degree rotated lateral position and neutral position38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%. | Drug | 30 degree rotated lateral position, neutral position |
Primary outcome
minimum alveolar anesthetic concentration of endotracheal intubation
Time frame: The sevoflurane concentration is obtained when tracheal intubated immediately.
To compare the minimum alveolar anesthetic concentration of endotracheal intubation required for different head position in children with obstructive airway.
4 secondary outcomes
intubation score
Time frame: The intubation score is obtained when tracheal intubation was inserted immediately.
blood pressure include systolic and diastolic in mmHg
Time frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
heart rate in bpm
Time frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
bispectral index（BIS）, number from 100 (awake) to 40-60(anesthetic status)
Time frame: Baseline and every 1 minutes until 10 minutes after insertion of the endotracheal intubation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Background: PubMed 8615504Tanaka S, Tsuchida H, Nakabayashi K, Seki S, Namiki A. The effects of sevoflurane, isoflurane, halothane, and enflurane on hemodynamic responses during an inhaled induction of anesthesia via a mask in humans. Anesth Analg. 1996 Apr;82(4):821-6. doi: 10.1097/00000539-199604000-00025.
- Background: PubMed 1994760Yasuda N, Lockhart SH, Eger EI 2nd, Weiskopf RB, Liu J, Laster M, Taheri S, Peterson NA. Comparison of kinetics of sevoflurane and isoflurane in humans. Anesth Analg. 1991 Mar;72(3):316-24. doi: 10.1213/00000539-199103000-00007.
- Background: PubMed 14564561Wajima Z, Inoue T, Yoshikawa T, Imanaga K, Ogawa R. Changes in hemodynamic variables and catecholamine levels after rapid increase in sevoflurane or isoflurane concentration with or without nitrous oxide under endotracheal intubation. J Anesth. 2000;14(4):175-9. doi: 10.1007/s005400070001.
- Background: PubMed 10910489Goff MJ, Arain SR, Ficke DJ, Uhrich TD, Ebert TJ. Absence of bronchodilation during desflurane anesthesia: a comparison to sevoflurane and thiopental. Anesthesiology. 2000 Aug;93(2):404-8. doi: 10.1097/00000542-200008000-00018.
- Background: PubMed 2894106Helbo-Hansen S, Ravlo O, Trap-Andersen S. The influence of alfentanil on the intubating conditions after priming with vecuronium. Acta Anaesthesiol Scand. 1988 Jan;32(1):41-4. doi: 10.1111/j.1399-6576.1988.tb02685.x.
- Background: PubMed 22017661Makkar JK, Ghai B, Bhardwaj N, Wig J. Minimum alveolar concentration of desflurane with fentanyl for laryngeal mask airway removal in anesthetized children. Paediatr Anaesth. 2012 Apr;22(4):335-40. doi: 10.1111/j.1460-9592.2011.03712.x. Epub 2011 Oct 21.
- Background: PubMed 9135350Thwaites A, Edmends S, Smith I. Inhalation induction with sevoflurane: a double-blind comparison with propofol. Br J Anaesth. 1997 Apr;78(4):356-61. doi: 10.1093/bja/78.4.356.
- The effects of premedication on inhaled induction of anesthesia with sevoflurane.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Li Jing Jie, M.D. study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane in people with Sevoflurane and Endotracheal Intubation, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 11 May 2018. 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 China. 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.
Are results available for this study?
Results are not available in the source record.
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?
minimum alveolar anesthetic concentration of endotracheal intubation (time frame: The sevoflurane concentration is obtained when tracheal intubated immediately.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03522402, which also lists 7 linked publications.
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 11 May 2018.